IBP Manager

Product Manager (Pharma)

Head of HSE, Horn of Africa

Team Lead - Global Trade Compliance

Customer Service Manager

Customer Service Associate Manager

Customer Service Representative - SAP

Scheduling & Production Planning Analyst

Electrical/Controls Technician

Lead Quality Specialist - Investigator

Responsibilities: Demand planning &amp; operations <ul><li>Owns the demand planning process, ensuring that it happens on a timely basis and all parties are compliant with the process.</li><li>Partner with the commercial teams to understand and drive key requirements along with timely visibility of opportunities and risks enabling timely decisions.</li><li>Manage the day-to-day relationship with the distributors from a planning point of view.</li><li>Responsible for delivering orders on time, forecast accuracy, OTIF and IBP KPIs. IBP process &amp; maturity progress</li><li>Work closely with IBP director on process maturity and IBP cycle</li><li>Implement it through process, tools, leadership, change management Partner with other functions in the Long-Term Planning</li><li>Supervise building blocks creation and work closely with finance during the budgeting process (Commercial, Supply &amp; Financial)</li><li>Proactive management of gaps &amp; risks/opps, follow thru to capture full value of initiatives or gaps Take part in IBP Monthly and Quarterly Operational Disciplines aligned to Playbook</li><li>Gap Management: Ensure monthly cadence, and bring one number across the system, identify gaps &amp; risks/opps, monthly review of KPI’s and improvement actions</li><li>S&amp;OE: enable S&amp;OE discipline with Demand and Customer Development leadership – ensuring visibility and action plans for sales and demand, connecting with Finance</li><li>Reconcile variables between Gap and S&amp;OE</li><li>Drive alignment to a single number signed off by country manager</li><li>As the IBP manager, you will lead the end-to-end planning of the entire portfolio for GULF markets from a demand and S&amp;OP perspective.</li><li>You will also be responsible to provide the commercial and finance teams with the right visibility of forecasts, opportunities, and risks so that the business can make informed decisions.</li><li>You will be key to drive a culture of growth and excellence, discipline, and accountability for the business objectives; promoting behaviors that support a one team approach to business planning.</li><li>The individual has an integrated perspective of the business, connecting dots and challenging solutions to ensure strategic alignment with the delivery of short- and long-term objectives with focus on E2E execution excellence.</li></ul> Requirements: <ul><li>Preferably Masters Degree in a Business/ Finance/ Engineering/ Bus-Related field</li><li>Must have commercial understanding – 1-2 yrs in customer facing role in Supply/Commercial</li><li>Experience in S&amp;OP or IBP process: Building fact-based plans or working with demand signals to optimize results in the market: 4-5 years minimum</li><li>English proficiency</li><li>Upto 7 years of related work experience in FMCG</li><li>Capabilities needed of leadership, structured and critical thinking, clear communication, and people skills, analytical</li></ul>

Overview: <ul><li>We are seeking a dynamic and results-driven Product Manager to join our team.&nbsp;</li><li>This position will play a key role in the development, launch, and lifecycle management of products. The ideal candidate with have a strong understanding of the pharmaceutical industry, market trends, and regulatory processes, along with excellent strategic and communication skills.</li></ul> Responsibilities: Product Strategy &amp; Development: <ul><li>Define and execute the product strategy for assigned therapeutic areas/products.</li><li>Work cross-functionally with internal teams to ensure product development and delivery aligns with market needs.</li><li>Lead the creation and execution of product launch plans, ensuring timely market&nbsp;</li><li>entry.</li></ul> Market Research &amp; Analysis: <ul><li>Conduct market analysis to identify customer needs, competitor products, and emerging trends within the pharmaceutical industry.</li><li>Analyze clinical trial data and product performance to provide insights for product positioning and lifecycle management.</li></ul> Cross-functional Collaboration: <ul><li>Collaborate with Sales and Marketing teams to develop promotional strategies and sales tools for product launches.</li><li>Work closely with regulatory affairs to ensure compliance with local and global regulations.</li></ul> Lifecycle Management: <ul><li>Develop and execute product lifecycle management plans, including post-launch support, updates, and potential product enhancements.</li><li>Monitor product performance and provide recommendations for improvements or&nbsp;</li></ul> Stakeholder Communication: <ul><li>Serve as the product expert and primary point of contact for internal stakeholders regarding product details, progress, and updates.</li><li>Communicate product strategies and key milestones to senior leadership, ensuring&nbsp;alignment with organizational goals.</li></ul> Financial &amp; Budget Oversight: <ul><li>Prepare and manage product budgets, ensuring efficient resource allocation.</li><li>Track and report on product financial performance, including sales forecasts, market share, and ROI.</li></ul> ﻿Requirements: <ul><li>Bachelor’s degree in Pharmacy, Life Sciences, Business, or related field&nbsp;</li><li>3-5 years of experience in product management, preferably within the pharmaceutical or&nbsp;</li><li>healthcare industry.</li><li>Proven track record of successfully launching and managing pharmaceutical products.</li><li>Excellent strategic thinking, problem-solving, and decision-making abilities.</li><li>Strong communication and interpersonal skills, with the ability to collaborate across diverse&nbsp;</li><li>teams.</li><li>Ability to analyze data, forecast trends, and translate insights into actionable strategies.</li><li>Experience with lifecycle management and managing product P&amp;L is highly desirable.</li></ul>

Role Description: <ul><li>To ensure that work processes are implemented as designed and comply with established policies, processes, and procedures.</li><li>Ensure compliance with both standard and regulatory requirements as relevant for all entities in the Horn of Africa.</li></ul> Responsibilities: <ul><li>Play a lead role in promoting and developing safe work culture that embraces zero harm through health, safety and environmental awareness by stimulating active involvement and interaction at all organizational levels.</li><li>Maintain the safety standards to be in compliance with company HSE policies and countries legislations.</li><li>Collate and analyse data for trend analysis &amp; statistics at regular intervals to achieve continual improvement on all aspects of HSE and related training of personnel.</li><li>Involve in high level investigation &amp; Investigate accidents effectively and determine root cause analysis along with project clients.</li><li>Identify and act upon opportunities for improvement to safety related matters.</li><li>Liaise with project managers / client / stakeholders as deemed necessary for discussion on project safety matters and resolve issues.</li><li>Drive and support the business in implementing HSE standards for contracts and suppliers through the HSE team in each business unit.</li><li>Provide advice and support to line management for conducting risk assessments and ensuring that operational risks are proactively and appropriately managed.</li><li>Overview and ensure proper adherence to ICAM procedure for incident investigations and implement effective control measures for closure of the gaps identified to prevent recurrence.</li><li>Evaluate and ensure emergency response preparedness through regular emergency mock drills and upkeep of the emergency response procedures.</li></ul> Requirements: <ul><li>Post Graduate qualification in Safety with at least 15 yrs work experience in the field of Safety Management and Training; OR</li><li>Graduate in any field with Diploma in Industrial Safety with at least 10 yrs work experience in Safety Management and Training; OR</li><li>Knowledge of ISO and other International Standards related to Quality, Environment and Occupational Health &amp; Safety</li><li>Lead Auditor certification in Quality Management System</li><li>Computer literate in Microsoft Office applications</li><li>Very good communication in English 	</li></ul>

Responsibilities: Trade Compliance Activities in the BU: <ul><li>Execute trade operations and provide compliance oversight for the assigned BU to ensure compliance with import/export laws and regulations in UK, US &amp; Indian SCOMET Export Controls</li><li>Maintain trade operations and compliance activities in accordance with policies, procedures, and controls, in collaboration with&nbsp;</li></ul> key stakeholders throughout the BU: <ul><li>Act as a point of contact for BU stakeholders on trade-related matters.</li><li>Work with BU stakeholders and counsel to understand business changes and develop trade-related solutions/strategies and controls to ensure compliance</li><li>Maintain BU-level Key Performance Indicators (KPIs) and reporting to ensure efficiency and effectiveness of the operations</li><li>Partner with Trade Compliance Professionals and Stakeholders across the Enterprise</li><li>Partner with GTS Governance to monitor trade compliance regulatory and legislative changes, assess the potential impact to the BU, and determine the necessary actions and communications to the appropriate stakeholders</li><li>Work with GTS Governance teams to conduct trade compliance audits and oversee corrective action plans</li><li>Partner with GTS Governance to develop and administer effective trade compliance training as required throughout the region and organization&nbsp;</li><li>Ensure appropriate utilization of the GTS Operations Service Centre for product classification (import and export), restricted party screening, and duty savings compliance, and otherwise ensure proper country of origin determination, valuation, and admissibility</li><li>Work with the Operational Service Centres to identify, evaluate and administer opportunities to facilitate trade in a cost-effective and compliant manner (e.g. make use of applicable Free Trade Agreements, Duty Drawback, First Sale for Export, Foreign Trade Zones, etc.)&nbsp;</li><li>Establish and maintain relationships with internal functions, including corporate functions, to encourage awareness of global trade compliance issues, pro-actively identify trade risk and threats, and develop appropriate trade compliance controls</li></ul> Talent Development &amp; Leadership: <ul><li>Create a culture of engagement and performance in alignment with core values&nbsp;</li><li>Lead by example and act with empathy</li></ul> Requirements: <ul><li>Experience in UK, US &amp; Indian SCOMET Export Controls</li><li>SAP &amp; GTS experience</li><li>Customs Compliance experience</li><li>Management of a team</li><li>Success in the role requires strong analytical and creative problem-solving skills, highly developed oral and written communication skills, and the ability to work with interdisciplinary teams (internal and external) to drive issues and projects to conclusion.&nbsp;&nbsp;</li></ul> In addition, successful candidate will have the following qualifications, experience, and skills: <ul><li>Bachelors degree required (international business, supply chain, law, or related field)</li><li>3+ years’ experience in global trade compliance</li><li>Functional knowledge of import and export regulations and familiarity with customs practices in countries across the region</li><li>Proven ability to work with variety of business groups, including supply chain, legal, procurement and finance</li><li>Ability to foster teamwork and internal and external relationships</li><li>Excellent organizational habits and priority management&nbsp;</li><li>Customer focused with a commitment to quality</li><li>Travel may be necessary in fulfillment of responsibilities</li></ul>

Responsibilities: Strategic Leadership and Team Development:&nbsp; <ul><li>Lead, mentor, and manage a team of up to 5-8 Analysts, Specialists, and Associate Managers.&nbsp;</li><li>Build a culture of high performance, ensuring team engagement, development, and retention to meet organizational goals.</li></ul> Customer and Stakeholder Collaboration:&nbsp; <ul><li>Serve as a strategic partner for key internal and external stakeholders, including Sales, Supply Chain, and Distribution leaders, to resolve escalated customer service issues and deliver seamless order-to-delivery (OTD) solutions.</li></ul> Operational Excellence and Process Improvement:&nbsp; <ul><li>Drive initiatives that enhance efficiency and reduce costs across customer service operations.&nbsp;</li><li>Implement continuous improvement strategies using methodologies like Six Sigma or LEAN while ensuring compliance with organizational policies, including GAAP and SOX requirements.</li></ul> Data-Driven Decision Making:&nbsp; <ul><li>Analyze KPIs, SLAs, and service metrics to identify trends, assess performance, and develop strategies to optimize customer service and supply chain operations.</li></ul> Strategic Planning and Execution:&nbsp; <ul><li>Collaborate with senior leadership to design and execute strategic customer service plans aligned with Kellanova’s broader business objectives.&nbsp;</li><li>Partner with third-party service providers to promote operational effectiveness and supply chain efficiency.</li></ul> Requirements:﻿﻿ <ul><li>Bachelor’s degree required, with at least two-three years of experience in customer service, supply chain, or a related field.</li><li>Prior experience in a leadership role is essential.</li><li>Strong track record of managing and developing high-performing teams, fostering a culture of accountability, and driving employee engagement.</li><li>Advanced proficiency in ERP systems (e.g., SAP) and Microsoft Office, with a solid understanding of order-to-delivery and supply chain operations.</li><li>Ability to analyze complex data, identify trends, and develop innovative, data-driven solutions to address customer service challenges and improve processes.</li><li>Exceptional verbal and written communication skills in English, with experience working effectively across functions, regions and presenting to senior leadership.</li><li>Expertise in implementing continuous improvement initiatives using Six Sigma, LEAN, or similar methodologies to achieve operational efficiencies and cost reductions.</li><li>Strong organizational skills with the ability to prioritize and manage multiple initiatives, consistently meeting deadlines and exceeding performance objectives.</li></ul>

Responsibilities: <ul><li>Leadership and Team Management: Lead, mentor, and engage in a team of 3-5 Analysts and Senior Analysts. Drive a high-performance culture through coaching, feedback, and development, ensuring strong team engagement and retention.</li><li>Track and analyze KPIs, SLAs, and team performance metrics, using insights to drive improvements in quality, efficiency, and customer experience.</li><li>Customer and Stakeholder Collaboration: Build strong relationships with internal and external stakeholders, including senior leadership, supply chain, and sales partners, to identify trends and resolve escalated issues.</li><li>Serve as the key point of contact for critical customer service challenges.</li><li>Process Optimization and Continuous Improvement: Proactively identify trends and inefficiencies in the order-to-delivery (OTD) process. </li><li>Leverage analytics and tools like SAP to implement process improvements that enhance customer satisfaction and reduce costs.</li><li>Lead and participate in special projects, system testing, and process pilots to support OTD innovation. Identify and implement new tools and methodologies to enhance operational efficiency.</li><li>Data-Driven Insights and Problem Solving: Analyze complex data to uncover actionable insights and present recommendations to leadership and customers.</li><li>Ensure compliance with policies, including GAAP and SOX, while driving OTD performance metrics.</li><li>Customer-Centered Culture: Foster a service-oriented mindset across the team by championing proactive communication, anticipating customer needs, and delivering innovative solutions that align with business goals.</li><li>Lead a small team, ensuring high performance and engagement.</li><li>Serve as the escalation point for complex order-to-delivery (OTD) issues.</li><li>Track KPIs &amp; analyze trends to improve service quality.</li><li>Identify continuous improvement opportunities (LEAN, process automation).</li><li>Work with internal &amp; external stakeholders to optimize customer service operations.</li></ul> Requirements: <ul><li>Bachelor’s degree required, with supervisory experience managing teams and customer relationships.</li><li>Experience analyzing complex datasets, identifying trends, and presenting actionable insights. Proficient in ERP systems (e.g., SAP) and Microsoft Office, with a solid understanding of order-to-delivery and supply chain operations.</li><li>Demonstrated ability to lead and develop teams, with a focus on engagement, retention, and high performance.</li><li>Strong collaboration and relationship-building skills with customers and cross-functional teams. </li><li>Experience handling escalated customer issues is essential.</li><li>Knowledge in implementing continuous improvement initiatives using Six Sigma, LEAN, or similar methodologies to achieve operational efficiencies and cost reductions.</li><li>Fluent level of English is mandatory with exceptional verbal and written communication skills</li><li>Strong organizational and time management skills, with the ability to prioritize competing demands and deliver results in a dynamic, fast-paced environment.&nbsp;</li></ul>

Role Description: <ul><li>Customer Service Teams interact with customers, company sales and/or service representatives to handle a variety of pre-sales or post-sales service functions.</li><li>They take and process transactions via phone, internet and correspondence from customers and representatives and respond to inquiries about products or services.</li><li>They may promote and sell our companys products or services as well as investigate and resolve customer complaints.</li><li>A key area of focus is to develop strong business relationships via Extraordinary Customer Experience strategy.</li><li>Customer Service Representatives (CSRs) are crucial as they serve as the primary point of contact for both customers and the company.</li><li>They will lead the order-to-cash process, ensuring seamless communication and efficient handling of customer inquiries, orders, and issues.</li><li>Their responsibilities include managing customer interactions, processing orders, addressing concerns, and coordinating with internal teams to ensure timely and accurate delivery of products and services.</li><li>This role is vital in maintaining customer satisfaction and fostering strong, long-term relationships.&nbsp;</li></ul> Responsibilities: <ul><li>Deliver extraordinary customer experience by providing our customer with world class customer service</li><li>Respond promptly to customer inquiries via phone, email.</li><li>Provide detailed information about products, services, and order status.</li><li>Resolve customer complaints and issues efficiently and professionally.</li><li>Process customer orders accurately and efficiently.</li><li>Track order progress and ensure timely delivery.</li><li>Coordinate with planner, logistics, sales, product management and quality teams to fulfill customer</li><li>Serve as the primary point of contact between customers and the manufacturing team.</li><li>Communicate any changes in order status, delays, or issues to customers promptly.</li><li>Prepare and deliver order confirmations, shipping notifications, and other relevant information.</li><li>Maintain accurate and up-to-date customer records and order documentation.</li><li>Generate regular reports on order status, customer interactions, and other relevant metrics.</li><li>Identify trends and provide insights to improve customer service processes.</li><li>Identify and troubleshoot issues related to orders, deliveries, and product quality.</li><li>Gather customer feedback and suggest improvements to products and services.</li><li>Participate in team meetings and training sessions to stay updated on products and processes.</li><li>Assist in the development and implementation of customer agreement and procedures.</li></ul> Requirements: <ul><li>Any Bachelor’s/ Business degrees or equivalent experience.</li><li>Comfortable with Night Shift.</li><li>SAP knowledge.</li><li>Supply chain knowledge.</li><li>SFDC experience (added advantage).</li></ul>

Job Description: <ul><li>We are seeking a highly motivated Scheduling &amp; Production Planning Analyst with expertise in inventory management and advanced Excel modeling skills.</li><li>The ideal candidate will have 2-3 years of experience in scheduling, production planning, and inventory management, with a strong ability to leverage Excel to optimize processes and improve efficiency.</li><li>A background in finance is an added advantage, helping to drive decisions on new business opportunities, cost analysis and budget management within production and inventory functions.</li><li>In this role, you will be responsible for developing and managing production schedules, optimizing inventory levels, forecasting demand, and analyzing data to support decision-making.&nbsp;</li><li>Your advanced Excel skills will be crucial in creating models for production, inventory planning, and reporting, while your understanding of finance will help identify cost-optimization opportunities.</li></ul> Responsibilities: Production Scheduling &amp; Planning: <ul><li>Develop and manage production schedules, ensuring efficient resource allocation (labor, equipment, raw materials) and meeting production deadlines. Work closely with cross-functional teams to align production goals with business objectives.</li></ul> Inventory Management: <ul><li>Monitor inventory levels and ensure alignment with production schedules.&nbsp;</li><li>Optimize inventory to minimize holding costs and reduce the risk of stockouts or overstock situations.</li></ul> <ul><li>Advanced Excel Modeling: </li></ul> <ul><li>Utilize advanced Excel skills to build and maintain models for production planning, inventory optimization, and scheduling. </li><li>This includes using pivot tables, complex formulas, forecasting, data visualization, and macros to enhance decision-making and operational efficiency.</li></ul> Forecasting &amp; Demand Planning: <ul><li>Work with sales, procurement, and other teams to develop accurate demand forecasts, ensuring production schedules are aligned with customer needs and market trends.</li></ul> Capacity &amp; Resource Planning: <ul><li>Analyze production capacity and resource availability, adjusting schedules and inventory management to meet changing demands and operational constraints.</li></ul> Cost Management &amp; Financial Analysis: <ul><li>Collaborate with finance teams to monitor production and inventory costs, identify inefficiencies, and help with cost optimization strategies.&nbsp;finance background will assist in budgeting and forecasting for production-related topics.</li></ul> Performance Reporting: <ul><li>Prepare and present regular reports on production performance, inventory levels, and key performance indicators (KPIs). Provide data-driven insights and recommendations to improve efficiency, reduce costs, and meet business goals.</li></ul> Process Optimization: <ul><li>Continuously assess and refine production planning, scheduling, and inventory management processes. Recommend and implement improvements to reduce waste, increase throughput, and optimize resource utilization.</li></ul> ERP System Utilization: <ul><li>Use ERP systems (SAP) to manage production and inventory data, ensuring accurate tracking of orders, materials, and resources.</li></ul> Requirements: <ul><li>Bachelor’s degree in supply chain management, Operations, Business, Finance, or a related field.</li><li>2-3 years of experience in scheduling, production planning, and inventory management.</li><li>Advanced proficiency in Microsoft Excel, including pivot tables, VLOOKUP, advanced formulas, forecasting models, macros, and data analysis.</li><li>Strong understanding of production scheduling, inventory management, and supply chain processes.</li><li>A background in finance or financial analysis is an added advantage, helping to identify cost-optimization opportunities and manage budgets effectively.</li><li>Familiarity with ERP systems (e.g., SAP) and other inventory management tools.</li><li>Strong analytical skills and the ability to interpret complex data and generate actionable insights.</li><li>Excellent communication and collaboration skills, with the ability to work cross-functionally with teams across the organization.</li><li>Detail-oriented with the ability to manage multiple priorities in a fast-paced environment.</li></ul> Preferred Qualifications: <ul><li>Certification in Supply Chain Management or Finance-related qualifications (e.g., MBA) is a plus.</li><li>Experience with data visualization tools (e.g., Power BI, Tableau) for reporting and dashboard creation.</li><li>Knowledge of production planning software or inventory management systems is beneficial.</li></ul>

Role Description: <ul><li>Position Overview: We are seeking a skilled and detail-oriented Electrical/Controls Technician to join our pharmaceutical operations team. </li><li>The successful candidate will be responsible for the installation, maintenance, troubleshooting, and repair of electrical control systems used in pharmaceutical manufacturing and packaging processes. </li><li>This role is critical to ensuring operational efficiency, product quality, and compliance with regulatory standards.&nbsp;</li></ul> Responsibilities:&nbsp; Installation and Maintenance:&nbsp; <ul><li>Install and maintain electrical control systems, PLCs (Programmable Logic Controllers), HMIs (Human-Machine Interfaces), and SCADA systems.&nbsp;</li><li>Perform routine preventive maintenance on electrical systems to minimize downtime and ensure continuous operation.&nbsp;</li><li>Test and validate electrical control systems during commissioning and upgrades.&nbsp;</li></ul> Troubleshooting and Repairs:&nbsp; <ul><li>Diagnose and resolve malfunctions in electrical systems, instrumentation, and automation equipment.&nbsp;</li><li>Utilize diagnostic tools, schematics, and software to identify root causes of system failures.&nbsp;</li><li>Repair or replace faulty components, including relays, sensors, actuators, and circuit boards.&nbsp;</li></ul> System Optimization:&nbsp; <ul><li>Program, configure, and optimize PLCs, HMIs, and VFDs (Variable Frequency Drives) to improve system performance and efficiency.&nbsp;</li><li>Assist in the design and implementation of new electrical control systems for process improvements and new projects.&nbsp;</li><li>Conduct system performance tests to ensure compliance with specifications and regulatory requirements.&nbsp;</li></ul> Documentation and Compliance:&nbsp; <ul><li>Maintain accurate documentation of electrical control systems, including wiring diagrams, and maintenance logs.&nbsp;</li><li>Ensure all activities comply with GMP (Good Manufacturing Practices), FDA, and other regulatory guidelines.&nbsp;</li><li>Participate in audits and provide technical expertise regarding control systems and maintenance records.&nbsp;</li></ul> Safety and Training:&nbsp; <ul><li>Adhere to safety protocols and ensure that all electrical work complies with NFPA, OSHA, and company standards.&nbsp;</li><li>Conduct risk assessments for electrical systems and implement appropriate safety measures.&nbsp;</li><li>Provide technical training to maintenance personnel on electrical systems and best practices.&nbsp;</li></ul> Collaboration:&nbsp; <ul><li>Work closely with engineering, production, and quality assurance teams to ensure electrical systems support manufacturing requirements.&nbsp;</li><li>Communicate effectively with equipment vendors and contractors for system upgrades and troubleshooting.&nbsp;</li></ul> Requirements: <ul><li>Education: Associate’s degree in electrical engineering, electronics, or a related field.&nbsp;</li><li>Experience: Minimum of 3-5 years in electrical controls, automation, or instrumentation, preferably in a pharmaceutical or regulated industry.&nbsp;</li><li>Technical Skills: Proficiency in PLC programming (e.g., Allen-Bradley, Siemens).&nbsp;</li><li>Strong understanding of electrical schematics, control wiring, and instrumentation.&nbsp;</li><li>Familiarity with SCADA systems and industrial networks.&nbsp;</li><li>Knowledge of GMP and regulatory standards in the pharmaceutical industry.&nbsp;</li></ul> Certifications: <ul><li>Relevant certifications (e.g., Journeyman Electrician, ISA Technician Certification) are a plus.&nbsp;</li></ul> Key Competencies:&nbsp; <ul><li>Analytical problem-solving skills with attention to detail.&nbsp;</li><li>Ability to work independently and as part of a team.&nbsp;</li><li>Excellent communication and documentation skills.&nbsp;</li><li>Commitment to safety, quality, and regulatory compliance.&nbsp;</li></ul>

Role Description: <ul><li>The Lead Quality Specialist - Investigator serves as the primary investigator for Out of Specification (OOS), Out of Trend (OOT), Non-Official Events (NOE), and other laboratory investigations within the Quality Control (QC) department.</li><li>This role is responsible for initiating, conducting, and closing laboratory investigations while collaborating with cross-functional teams to ensure accurate root cause analyses, effective Corrective and Preventive Actions (CAPAs), and adherence to compliance requirements.</li><li>Frequent interaction with QC, QA, Manufacturing, and other departments is essential to achieve timely investigation closure and process improvements.</li></ul> Scope of Authority <ul><li>Provides investigative and compliance support to the QC laboratory, with a focus on maintaining quality standards and supporting cross-departmental collaboration.</li></ul> Responsibilities; 1. Initiation, Execution, and Closure of QC Lab Investigations (60%) <ul><li>Initiate and conduct OOS, OOT, and NOE investigations in alignment with procedural timelines.</li><li>Provide support and guidance to QC teams during execution, writing, and closure of investigations.</li><li>Conduct interviews with QC personnel to gather information and complete investigation reports in Trackwise.</li><li>Utilize laboratory software for root cause and impact analyses.</li><li>Conduct quality walkthroughs in the QC laboratory to identify and address compliance issues.</li><li>Regularly communicate with departmental leaders to provide updates on investigation progress and documentation needs.</li></ul> 2. Corrective and Preventive Actions (CAPAs) (30%) <ul><li>Collaborate with cross-functional teams to identify, implement, and monitor CAPAs within QC laboratories.</li><li>Assist with training, procedure updates, and monograph revisions based on investigation outcomes.</li><li>Provide recommendations for process improvements to support continuous improvement initiatives.</li></ul> 3. Compliance (10%) <ul><li>Identify compliance risks, propose remediation strategies, and lead the implementation of solutions.</li><li>Provide compliance expertise, training, and support to QC and other impacted departments.</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor’s degree in Chemistry, Biology, or Pharmaceutical Sciences.</li><li>Minimum of 4 years of experience in a pharmaceutical manufacturing environment.</li></ul> Knowledge <ul><li>Proficiency in HPLC, GC, and related chromatography methods and equipment.</li><li>Working knowledge of Chromatographic Data Systems (e.g., Empower preferred) and applications such as Trackwise.</li><li>Comprehensive understanding of QC lab testing and data integrity principles.</li><li>Familiarity with regulatory requirements, including 21-CFR-210, 21-CFR-211, ICH Guidelines, and Compendia standards (USP, EP, JP, etc.).</li></ul> Skills &amp; Abilities <ul><li>Strong technical writing and documentation skills.</li><li>Problem-solving and decision-making expertise.</li><li>Excellent communication skills with peers, chemists, and senior management.</li><li>Critical thinking and root cause analysis proficiency.</li><li>Customer and stakeholder focus, with a strong commitment to quality and integrity.</li><li>Physical &amp; Mental Requirements</li><li>Ability to sit, stand, walk, and use a computer for extended periods.</li><li>Exposure to moderate noise levels and various chemicals in an FDA- and DEA-regulated environment.</li><li>Ability to wear personal protective equipment (e.g., gloves, respirators).</li><li>Specific vision requirements include close vision and color vision.</li></ul>

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95 operational improvements Jobs found

IBP Manager

Product Manager (Pharma)

Head of HSE, Horn of Africa

Team Lead - Global Trade Compliance

Customer Service Manager

Customer Service Associate Manager

Customer Service Representative - SAP

Scheduling & Production Planning Analyst

Electrical/Controls Technician

Lead Quality Specialist - Investigator

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95 operational improvements Jobs found

IBP Manager

Product Manager (Pharma)

Head of HSE, Horn of Africa

Team Lead - Global Trade Compliance

Customer Service Manager

Customer Service Associate Manager

Customer Service Representative - SAP

Scheduling & Production Planning Analyst

Electrical/Controls Technician

Lead Quality Specialist - Investigator

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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WhiteCrow is on a mission to connect companies with the best talent across the globe.