Product Manager (Pharma)

Head of HSE, Horn of Africa

Payroll Analyst

Customer Service Analyst- OTD Analyst

Operation Supervisor

Lead Quality Specialist - Investigator

Talent Management Specialist

Advanced Quality Engineer

Advanced Quality Engineer Manager

Regulatory Affairs Manager

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:&nbsp; <ul><li>Provide effective and efficient on-site Payroll service ,contribute in company Philippine payroll and related programs (eg. tax, insurance, labor cost report, benefit programs) processing within established budgets, principles and regulations, laws and employment standards , manage the accurate and timely processing of payroll related activities.&nbsp;</li><li>Work with plant operations and T&amp;A colleague to ensure time &amp; attendance data smoothly flow into payroll process and ensure payroll accuracy&nbsp;</li><li>Responsible to employee’s query about payroll&nbsp;</li><li>Responsible to payroll related files documentation and ensure meet audit requirement&nbsp;</li><li>Act as advisor to business on country policies, local regulations and company policies, keep abreast of all Payroll regulatory related issues, foresee potential risk vs current practice and raise for discussion, drive for risk elimination to ensure compliance&nbsp;</li><li>Support HRBP to develop site pay policy/procedures</li><li>Responsible for audits and ensure accuracy and data integrity, implement related action plan as audit needs&nbsp;</li><li>Continuously review and enhance payroll processes/programs and implement improvement, manage global or regional payroll integration or harmonization program, promote global or regional payroll system at site and ensure the adoption rate .</li><li>Provide on-site HR services operations assigned by manager.</li></ul> Requirements: <ul><li>Bachelor’s degree, human resources education or equivalent&nbsp;</li><li>7 years progressive payroll experience as independent Payroll Analyst&nbsp;</li><li>Familiarity with PH agencies such as SSS, PhilHealth, and Pag-ibig, as well as tax regulations (BIR).</li><li>Working experience in international enterprise&nbsp;</li><li>Good knowledge of country and local Payroll laws&nbsp;</li><li>Breadth of experience in Payroll disciplines, including data management, metrics and measurement&nbsp;</li><li>Proficient in MS Office (incl. Word, Excel and PowerPoint)&nbsp;</li><li>Experience with tax systems and reporting&nbsp;</li><li>Good service mindset and collaboration spirit&nbsp;</li><li>Experience with time and attendance systems preferred</li></ul>

Responsibilities:: <ul><li>Customer Relationship Management: Serve as the primary point of contact for assigned customers and sales partners, managing the fulfillment of customer orders to ensure on-time and in-full delivery (OTIF). Communicate effectively with stakeholders to reduce pricing discrepancies, resolve case fill issues, and address delivery delays.</li><li>Process Optimization and Problem Solving: Identify opportunities for continuous improvement within the order management process such as pricing discrepancies, OS&amp;D, and returns. Leverage tools such as SAP, Microsoft Excel and Celonis. Proactively implement solutions to enhance customer service initiatives and deliver consistent results.</li><li>Collaboration and Stakeholder Engagement: Partner with internal and external stakeholders, including supply chain, finance, sales teams, brokers, IT, and transportation carriers, to resolve logistical challenges and enhance the overall customer experience.</li><li>Performance Monitoring and Policy Compliance: Evaluate and ensure adherence to service-level agreements (SLAs), key performance indicators (KPIs), and internal policies, including GAAP, SOX, and audit requirements. Track and report performance metrics to identify improvement opportunities.</li><li>Capability Building and Innovation: Foster a culture of learning by participating in training and development programs. Contribute to special projects and continuous improvement initiatives, identifying innovative solutions to enhance process efficiency and quality.</li><li>Manage order processing and ensure on-time and in-full (OTIF) deliveries.</li><li>Support customer requests and help resolve basic order issues.</li><li>Track &amp; report KPIs (order accuracy, service levels).</li><li>Collaborate with internal teams to optimize OTD processes.</li><li>Learn and grow within the customer service and supply chain field. Must-Have Skills: Customer service experience (OTD, logistics, or related fields).</li><li>Sense of urgency &amp; problem-solving (handle daily tasks efficiently).</li></ul> Requirements: <ul><li>Bachelor’s degree in business administration, Logistics, or a related field.</li><li>Strong computer skills, including proficiency with ERP systems (e.g., SAP) and Microsoft Office.</li><li>Experience working with Order to Delivery Customer Service/support.</li><li>Exceptional time management and organizational capabilities, with the ability to handle competing priorities.</li><li>Advanced Analytical experience, strategic mindset, time management, problem-solving, and decision-making skills.</li><li>Excellent verbal and written communication abilities in a professional setting.</li><li>Advanced English level is mandatory, as this role provides services to US. Customer Service Analyst – OTD Analyst The Analyst role is more like an entry-level, focusing on day-to-day operations and order fulfillment – we ask at least 1 years of experience in Customer Service role for Logistics, transportation Team Structure:</li><li>Reports to the Team Lead.</li><li>Works with internal teams (Finance, Sales, Supply Chain).&nbsp;</li><li>Good communication skills (work with different teams). Willingness to learn (quick adaptation to SAP &amp; internal processes).</li><li>Fluent English (for working with US customers).</li><li>Support to North America</li></ul>

Overview: <ul><li>This position will lead within operations both manufacturing and packaging teams in Somerset, NJ.</li><li>Reporting to one of the operation Managers, operation Supervisors lead teams in designated technology areas and product trains at the site, directs and coordinates the activities of department operators , conduct performance reviews, interact with support departments, and drive efficiencies initiatives within operations.</li><li>The Somerset, NJ site produces oral solid and liquid dosage form pharmaceuticals.</li></ul> Responsibilities: <ul><li>Will lead oral solid dosage form manufacturing and packaging teams as assigned.&nbsp;</li><li>First shift leader with start time 6:00 am to 2:00 pm (8 hr. - 5 days/week) or 5:45 am to 4:00 pm (10 hr, 4 days/week).&nbsp;</li><li>Discussion with Manager on the right fit and team needs.&nbsp;</li><li>Develop, recommend, and implement measures to improve production methods, equipment performance, and quality of product&nbsp;</li><li>Track production processing and material management in SAP&nbsp;</li><li>Daily metrics reporting such as variances in production, labor hours and downtime, track and report operator performance and attendance&nbsp;</li><li>Oversee completion of GPM records and standard operating procedures required within operations&nbsp;</li><li>Participate and develop plans for improving a safe work place and culture of identifying, reporting, and fixing unsafe conditions and behaviors within the site and our work teams.&nbsp;</li><li>Work with cross functional groups to accomplish objectives including finance, procurement, operations, supply chain, maintenance, facilities, technical services, security, quality assurance, and quality control as appropriate.&nbsp;</li><li>Under the direct supervision of a leader and able to communicate progress, needs, requirements, and issues effectively for assigned work for yourself and your teams.&nbsp;</li><li>Carry out all duties in accordance with Good Manufacturing practices (cGMP) and standard operations procedures.&nbsp;</li></ul> Requirements: Qualifications and Education Requirements: <ul><li>Associates degree or higher preferred&nbsp;</li><li>5+ years of pharmaceutical packaging OR manufacturing experience&nbsp;</li><li>2+ years’ experience leading/supervising in a manufacturing environment&nbsp;</li><li>Working knowledge of SAP or another ERP system&nbsp;</li><li>Excellent written communication skills</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>

Overview: <ul><li>The Talent Management Specialist role focuses on talent management within the organization, primarily overseeing activities related to leadership development, promotion management, and identifying high-potential employees.&nbsp;</li><li>This role will also include some responsibilities related to HR business partnering for indirect labour employees.</li></ul> Responsibilities: Lead talent management initiatives, including:&nbsp; <ul><li>Designing leadership courses and development programs.</li><li>Managing promotion processes and staff development.</li><li>Reviewing talent with the leadership team.</li><li>Engage in HRBP activities for indirect labour employees (approx. 20% of the role).</li><li>Drive employee engagement strategies and L&amp;D initiatives.</li></ul> Requirements: Experience:&nbsp; <ul><li>Minimum of 8 years in talent management or a related field.</li><li>Experience in multinational companies is preferred.</li></ul> Education:&nbsp; <ul><li>Bachelor’s degree required.</li></ul> Skills:&nbsp; <ul><li>Fluent in English with strong presentation and communication skills.</li><li>Proficient in PowerPoint and other MS software.</li></ul> Diversity Focus:&nbsp; <ul><li>Preference for female candidates to promote diversity in leadership roles.</li></ul> Team Structure: <ul><li>The candidate will report directly to the Head of HR.</li><li>The team includes three HR business partners focused on plant HR and C&amp;B tasks.</li></ul>

Responsibilities: <ul><li>Organize and facilitate Design Review (DR) and Design Failure Modes &amp; Effects Analysis (DFMEA) reviews.&nbsp;</li><li>Implement quality planning and controls for prototype and/or sample builds and manage build records and documents.</li><li>Complete measurement system analysis for inspection systems and gages to be utilized for the project.</li><li>Review and analyze samples, quality issues and improvement actions during developing stage.&nbsp;</li><li>Involve and drive for design verification before design freeze and product qualification testing before Gate5 of project.</li><li>Conduct and analyze process capability studies in support of Final Tool Approval (FTAR) for all tools and production lines associated with the project using the Comprehensive Tool</li></ul> Approval Report (CTAR): <ul><li>Implement quality controls and documentation needed for production shop floor.</li><li>Monitor process capability and oversee ongoing corrective actions as required.</li><li>Review and approve the measurement and cosmetic inspection.</li><li>Support the customer and quality system audit as required</li></ul> Talent Development &amp; Leadership: <ul><li>Support a culture of engagement and performance in alignment with TE’s core values&nbsp;</li><li>Provide timely, thoughtful feedback to support your team’s growth and development</li><li>Lead by example and act with empathy</li></ul> Requirements: <ul><li>At least Bachelor degree in Electrical or Mechanical Engineering or related field</li><li>Quality control experience in cable assembly / connector / Socket or relevant industry.</li><li>Good written and oral English communication.</li><li>Understand ISO9001 quality system.</li><li>Be good at SPC, FMEA, MSA, and 7-QC tools.</li><li>Experienced in Statistical Process control techniques.&nbsp;</li><li>Understand GD&amp;T definition and requirements.</li><li>Be good at APQP procedure and requirements.</li><li>Be familiar with EIA-364 test procedures.</li><li>Ability to foster teamwork and internal and external relationships.</li><li>Excellent organizational habits and priority management</li><li>Customer focused with a commitment to quality.</li><li>Internal / External Auditor</li><li>Six Sigma (Black/Green Belt)</li><li>Design of Experiments</li><li>Up level Communication</li><li>Strategic Planning</li><li>Skilled in using software (Mini Tab / JMP)</li><li>Quality Leader</li></ul>

Responsibilities: <ul><li>Organize and facilitate Design Review (DR) and Design Failure Modes &amp; Effects Analysis (DFMEA) reviews.&nbsp;</li><li>Implement quality planning and controls for prototype and/or sample builds and manage build records and documents.</li><li>Complete measurement system analysis for inspection systems and gages to be utilized for the project.</li><li>Review and analyze samples, quality issues and improvement actions during developing stage.&nbsp;</li><li>Involve and drive for design verification before design freeze and product qualification testing before Gate5 of project.</li><li>Conduct and analyze process capability studies in support of Final Tool Approval (FTAR) for all tools and production lines associated with the project using the Comprehensive Tool</li><li>Approval Report (CTAR).&nbsp;</li><li>Implement quality controls and documentation needed for production shop floor.</li><li>Monitor process capability and oversee ongoing corrective actions as required.</li><li>Review and approve the measurement and cosmetic inspection.</li><li>Support the customer and quality system audit as required</li></ul> Talent Development &amp; Leadership: <ul><li>Support a culture of engagement and performance in alignment with TE’s core values</li><li>Provide timely, thoughtful feedback to support your team’s growth and development</li><li>Lead by example and act with empathy</li></ul> Requirements: <ul><li>At least Bachelor degree in Electrical or Mechanical Engineering or related field</li><li>Quality control experience in cable assembly / connector / Socket or relevant industry.</li><li>Good written and oral English communication.</li><li>Understand ISO9001 quality system.</li><li>Be good at SPC, FMEA, MSA, and 7-QC tools.</li><li>Experienced in Statistical Process control techniques.&nbsp;</li><li>Understand Model Based Dimensioning (MBD) and requirements</li><li>Understand GD&amp;T definition and requirements.</li><li>Be good at APQP procedure and requirements.</li><li>Be familiar with EIA-364 test procedures.</li><li>Ability to foster teamwork and internal and external relationships.</li><li>Excellent organizational habits and priority management</li><li>Customer focused with a commitment to quality.</li><li>Internal / External Auditor</li><li>Six Sigma (preferred Black Belt)</li><li>Design of Experiments</li><li>Up level Communication</li><li>Strategic Planning</li><li>Skilled in using software (Mini Tab / JMP)</li><li>Quality Leader</li></ul>

Responsibilities: <ul><li>Ensure all products comply with applicable laws, regulations, and standards as per Indian laws</li><li>Stay updated on regulatory changes and assess their impact on the companys products or processes.</li><li>Either prepare or coordinate with originator, review, and submit regulatory documents such as dossiers, technical files, and applications for product approval or licensing.</li><li>To do necessary follow-ups with regulatory agencies to get approval of the medical devices/pharmaceutical products.</li><li>Work with Originator, and marketing teams to ensure product alignment with regulatory requirements.</li><li>Lead or assist in regulatory audits conducted by agencies or certification bodies.</li><li>Identify and mitigate regulatory risks that could impact product approvals or market access.</li><li>Develop and implement regulatory strategies to accelerate market entry and ensure sustained compliance.</li><li>Conduct training sessions for cross-functional teams on regulatory requirements and best practices.</li><li>Responsible to get the necessary documents which are going to be useful for registration purpose.</li><li>Usually, this registration application is done online, and you need to constantly keep a follow up with the regulatory team.</li><li>Responsible to liaise with the authority daily based on the requirements pertaining to document for the smooth transition with the regulator and submit regularly to the regulating authority to get the registration executed in a timely manner.</li><li>Front lining the entire process with respect to coordination with Originator, regulatory authority and in need be travel to Delhi for meetings.</li><li>The company has tied up with an agency to make sure there are no gaps and you will be responsible to liaise with the Agency who closely work with the government authority to satisfy the documentation requirements.</li><li>You will be also responsible to regularly interact and funnel the requirements with the agencies and the regulatory authorities.</li><li>Ensure all products comply with applicable laws, regulations, and standards as per Indian laws</li><li>Stay updated on regulatory changes and assess their impact on the companys products or processes.</li><li>Either prepare or coordinate with originator, review, and submit regulatory documents such as dossiers, technical files, and applications for product approval or licensing.</li><li>To do necessary follow-ups with regulatory agencies to get approval of the medical devices/pharmaceutical products.</li><li>Work with Originator, and marketing teams to ensure product alignment with regulatory requirements.</li><li>Lead or assist in regulatory audits conducted by agencies or certification bodies.</li><li>Identify and mitigate regulatory risks that could impact product approvals or market access.</li><li>Develop and implement regulatory strategies to accelerate market entry and ensure sustained compliance.</li><li>Conduct training sessions for cross-functional teams on regulatory requirements and best practices.</li></ul> Requirements: ﻿Skills and Qualifications <ul><li>Bachelors degree in Life Sciences, Pharmacy, Chemistry, Biomedical Engineering.</li><li>Advanced degree (e.g., MBA, MS, or Ph.D.) is an advantage.</li><li>Strong knowledge of regulatory requirements (CDSCO, FDA, EMA, MHRA, TGA, etc.) and global standards (ISO, ICH, etc.).</li><li>Excellent project management and organizational skills.</li><li>Ability to analyze and interpret complex regulations.</li><li>Proficient in regulatory writing and submission tools.</li><li>Strong communication and interpersonal skills.</li><li>Ability to manage multiple projects and meet deadlines.</li></ul> Experience <ul><li>7–8 years of experience in regulatory affairs, with a proven track record of successful submissions and approvals.</li><li>Experience in handling registration of Medical Devices and getting approval.</li></ul>

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87 investigation report writing Jobs found

Product Manager (Pharma)

Head of HSE, Horn of Africa

Payroll Analyst

Customer Service Analyst- OTD Analyst

Operation Supervisor

Lead Quality Specialist - Investigator

Talent Management Specialist

Advanced Quality Engineer

Advanced Quality Engineer Manager

Regulatory Affairs Manager

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87 investigation report writing Jobs found

Product Manager (Pharma)

Head of HSE, Horn of Africa

Payroll Analyst

Customer Service Analyst- OTD Analyst

Operation Supervisor

Lead Quality Specialist - Investigator

Talent Management Specialist

Advanced Quality Engineer

Advanced Quality Engineer Manager

Regulatory Affairs Manager

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

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