Operations Supervisor

DevOps Engineer

Quality Control Supervisor

Associate Software Engineer - AI/ML systems Gurugram/New York

Data Engineer / Senior / Supervisor

QC Chemist I

Role Description: <ul><li>Job Summary The Operations Supervisor is responsible for overseeing solid dosage pharmaceutical manufacturing and packaging activities during 2nd shift operations, 3:15pm to 11:45pm.&nbsp;</li><li>This role ensures that all production operations comply with cGMP, safety standards, and production schedules.</li><li>The operations supervisor will lead and support a team of leads and operators ensuring high quality output, operational efficiency, and a safe working environment.</li><li>Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&amp;L responsibility, etc.</li><li>Oversees and coordinates Manufacturing and Packaging operations.&nbsp;</li></ul> Responsibilities: Key Accountabilities: <ul><li>Accountability Lead and supervise operations in solid dosage manufacturing and packaging to ensure adherence to Master Formula and Master Packaging Records, SOP’s, and regulatory requirements (FDA, etc.).</li><li>Communicate with department leadership, set the shift schedule, and conduct shift huddle/communication at start of shift to ensure effective communication between shifts.</li><li>Ensure timely execution of production schedules.</li><li>Monitors manufacturing and packaging processes to ensure schedule is met within standards.</li><li>Review and complete shift documentation, including batch documentation, logbooks, etc.</li><li>Coordinate with Engineering and Quality Assurance to address any equipment issues that occur during the shift Support investigations for deviations that occur during the shift.</li><li>Assist in determining and implementing CAPA.</li><li>Provide training, guidance, and performance feedback for shift employees.</li><li>Ensure training requirements are met.</li><li>Support employee development and cross-training.</li><li>Executes procedures to complete tasks in a compliant and safe manner.</li></ul> Continuous Improvement <ul><li>Captures and reports metrics; troubleshoots downtime to increase operational efficiency.</li><li>Lead or participate in Continuous Improvement projects.</li><li>Troubleshoots and resolves process issues.</li></ul> Issues &amp; Deviations <ul><li>Performs defect evaluations and initiates production events.</li><li>Identifies, reports, and suggests resolutions for processing related issues.&nbsp;</li><li>Assists in the investigation of unplanned deviations.</li></ul> Teamwork and Collaboration <ul><li>Provides priorities for the off-shift operations, focusing resources on priority products.</li><li>Interfaces with supervisors and/or Quality personnel to inform of deviations or other line issues.</li><li>Continuous Training Ensures personnel are current with training requirements.</li><li>Stays current on SOPs and cGMPs.</li><li>Continuous Safety &amp; Compliance Contribute to safety audits.</li><li>Ensures out manufacturing/packaging activities safely, as required, on a daily basis.</li><li>Follows all safety and compliance procedures and participates in required training.</li><li>Adheres to all cGMP compliance/regulatory mandates and quality requirements.</li><li>Participate in safety teams, start-up discussions, incident debriefs, etc.</li><li>Ensures compliance with SOPs, Policies and Procedures as required by the Company and regulatory agencies.</li><li>Misc Other related duties as assigned to meet departmental and Company objectives.&nbsp;</li></ul> Requirements: Qualifications Education &amp; Experience: <ul><li>Minimal acceptable level of education, work experience and certifications required for the job Bachelor’s degree in pharmacy, Chemistry, Engineering, or a related discipline preferred, relevant experience my substitute.</li><li>Minimum of 3 years supervisory experience in pharmaceutical solid dosage manufacturing/packaging.&nbsp;</li><li>Knowledge Proficiency in a body of information required for the job e.g.</li><li>Knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Thorough knowledge of cGMP and FDA regulations.</li><li>Thorough knowledge of manufacturing and packaging operations.&nbsp;</li></ul> Skills &amp; Abilities: <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Demonstrated leadership, communication, and decision-making skills.</li><li>Ability to oversee and manage the daily operations of manufacturing and packaging. Ability to monitors processes to ensure schedule is met within standards.</li><li>Ability to analyze metrics and troubleshoot downtime.&nbsp;</li><li>Effectively interfaces with Quality Assurance to inform of deviations or other line issues.</li><li>Demonstrates the ability to work in collaboration with others as a part of a team.</li><li>Ability to lead in Continuous Improvement projects.</li><li>Possess technical writing skills.&nbsp;</li><li>Physical Requirements Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Must be able to stand for long periods of time (8- or 12-hour shifts), lift at least 35 pounds, climb ladders, wear a dust mask or respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.</li><li>Lead and supervise operations in solid dosage manufacturing and packaging to ensure adherence to Master Formula and Master Packaging Records, SOP’s, and regulatory requirements (FDA, etc.).</li><li>Communicate with department leadership, set the shift schedule, and conduct shift huddle/communication at start of shift to ensure effective communication between shifts.</li><li>Ensure timely execution of production schedules.</li><li>Monitors manufacturing and packaging processes to ensure schedule is met within standards.</li><li>Review and complete shift documentation, including batch documentation, logbooks, etc.</li><li>Coordinate with Engineering and Quality Assurance to address any equipment issues that occur during the shift Support investigations for deviations that occur during the shift.</li><li>Assist in determining and implementing CAPA.</li><li>Provide training, guidance, and performance feedback for shift employees.</li><li>Ensure training requirements are met.</li><li>Support employee development and cross-training.</li><li>Executes procedures to complete tasks in a compliant and safe manner.</li></ul>

Responsibilities: <ul><li>To provide operational support for the overall Agile DevOps Platform, which includes:&nbsp;</li><li>Drive thought leadership in DevOps practices.</li><li>Work closely with Machine Learning Engineers to automate model training, testing and deployment into production using Continuous Integration/Continuous Delivery (CI/CD)&nbsp;</li><li>Hands on implementation and maintenance of CI/CD pipelines&nbsp;</li><li>Work closely with Security Architect to integrate security best practice into the pipeline&nbsp;</li><li>Identify and resolve problems in a timely fashion&nbsp;</li><li>Maintenance and upgrading of platform tools&nbsp;</li><li>Continuous monitoring of health of Agile products</li></ul> Requirements: <ul><li>Bachelor Degree in Computer Science</li><li>5+ Years experience in AWS Services, EKS, Kibana&nbsp;</li><li>Well-versed in agile ways of working and familiar with common tools including JIRA and Confluence&nbsp;</li><li>Experience in working in cross-functional Agile teams&nbsp;</li><li>A strong technical foundation in the following:&nbsp;</li><li>Good working experience with cloud-based technologies and architectures (AWS, Azure or&nbsp;&nbsp;&nbsp;GCP). AWS know-how is preferred&nbsp;</li><li>Experience with CI/CD practices and systems (e.g. git, git flow, trunk-based development).&nbsp;</li><li>Experience and good knowledge of Containerization (docker etc.)&nbsp;</li><li>Container orchestration using Kubernetes</li><li>Scripting language (shell, ruby/jruby, perl, python, powershell etc.)&nbsp;</li><li>Monitoring and data collection tools (nagios, splunk, and etc.)&nbsp;</li><li>SCM tools (git, bitbucket)&nbsp;</li><li>Build tools (ant, nant, rake, etc.)&nbsp;</li><li>Packet management (rpm, npm and etc.)&nbsp;</li><li>Configuration management tools (Ansible, chef, Terraform, puppet etc.)&nbsp;</li><li>Microservices architecture&nbsp;&nbsp;</li></ul>

Role Description: <ul><li>A concise overview of the job The Supervisor, Quality Control is responsible for overseeing the day-to-day operations of the QC raw material testing group.</li><li>Supervision and enforcing cGMP’s, GLP’s, conducting investigations, method transfers, verifications of compendia methods and training of new employees.</li><li>All incumbents are responsible for following applicable Division &amp; Company policies and procedures.</li><li>Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority (capital, operating, etc.), P&amp;L responsibility, etc.</li><li>Supervisory responsibilities within a single site.</li></ul> Responsibilities: <ul><li>QC Lab Management- Supervise day-to-day operations of QC Laboratory to ensure that cGMP’s, GLP’s and all other applicable compendial requirements are met.</li><li>Ensure that the testing is done as per the approved monograph procedures, investigate and take corrective actions, document investigation findings and coordinate the approval process of investigations.</li><li>Interact with Planning, Purchasing, Supply Chain, Production, QA for timely release of raw materials, excipient and packaging components.</li><li>Coordinate Analytical Methods Transfer projects. Identify and implement procedures to reduce cost of goods.</li><li>Develop systems and processes for proactive management of laboratory logistics and instrumentation.</li><li>Oversee ordering of lab supplies in observance of Departmental Budget constraints.</li><li>Workload Management- Coordinate workload sharing with other groups in QC and develop action plans to improve the working environment and for maximization of laboratory efficiency.</li><li>Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst’s notebooks.</li><li>SOPs - Review/update SOP’s, procedures and monographs for the QC Group as needed.</li><li>Review and comment on the articles affecting QC in the USP Supplements and Pharmacopeial Forums.</li><li>Conduct periodic audits of the analyst notebooks and instrument logbooks to ensure compliance of cGMP’s.</li><li>Staff Development-Evaluate potential candidates for QC; performance evaluation of direct reports.</li><li>Provide training in all procedures/instrumentation/techniques, including but not limited to HPLC, UV-Vis, IR, and Raw Material, Finished Product, Stability testing. 15% Total	100% Qualifications&nbsp;</li></ul> Requirements: Education &amp; Experience <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>BS in chemistry or related discipline with 10+ years’ experience in pharmaceutical testing OR MS in Chemistry or related discipline with 7+ years’ experience in pharmaceutical testing.</li><li>3+ years’ QC lab supervisory experience in pharmaceutical industry.</li><li>Demonstrated management and leadership experience with strong interpersonal and influencing skills.</li></ul> Knowledge&nbsp; <ul><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Expert knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or SDS.</li><li>Strong knowledge and proficiency required with laboratory techniques/instruments, such as HPLC, GC, analytical balance, pipette, burette, oven, UV-vis spectrophotometer, dissolution tester, pH meter, etc.</li><li>Strong knowledge and proficiency preferred with Empower, Track Wise and Labware LIMS.</li></ul> Skills &amp; Abilities	 <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Organizational Support- Follows policies and procedures; completes administrative tasks correctly and on time; supports organizations goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.</li><li>Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.</li><li>Supervising People- Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates activities; is available to staff; provides regular performance feedback; develops subordinates skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services.; continually works to improve supervisory skills.</li><li>Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.</li><li>Demonstrated flexibility in carrying out varied assignments in a high-quality work environment.</li><li>Excellent written and oral communications skills with a strong emphasis on organizational capabilities.</li></ul> Physical Requirements	 <ul><li>Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Employee is frequently required to use hands to handle or feel.</li><li>The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and color vision.</li><li>The noise level in the work environment is usually moderate.</li><li>The work environment is representative of a group laboratory environment.</li><li>QC Lab Management, Workload Management, SOPs, Staff Development</li></ul>

Responsibilities: <ul><li>Design and build the next generation of the worlds best investment management technology platform, focusing on managing various investment lifecycle processes and investment research.</li><li>Integrate new AI services across the platform and Aladdin application ecosystem.&nbsp;</li><li>Refine business and functional requirements and translate them into scalable technical designs.</li><li>Collaborate with product engineering teams to implement comprehensive AI/ML-based solutions from start to finish.</li><li>Apply quality software engineering practices throughout the software development lifecycle.</li><li>Optimize the software delivery and workflow of the team.&nbsp;</li><li>Work with team members in a multi-office, multi-country environment.</li></ul> Requirements: <ul><li>B.S./M.S. degree in Computer Science, Engineering, or a related subject area with 2+ years of proven experience, or equivalent experience, for Associate positions and 4+ years, or equivalent experience, for Vice President.</li><li>Proficiency and hands-on experience in object-oriented programming with Java and Python.</li><li>Proficiency in designing and building scalable APIs and Microservices.</li><li>Experience with cloud platforms such as Azure (Preferred), AWS, or GCP.</li><li>Ability to reverse engineering existing applications.</li><li>Grit in the face of technical obstacles&nbsp;</li><li>Experience working in Agile development teams with excellent collaboration skills.</li></ul>

Role Description:The Data Engineering Senior Supervisor will lead a small team of data engineering professionals to design, build and operate high performance data centric products or solutions through the use of modern engineering practices and technologies.In this role, you will provide guidance to ensure the delivered data centric products or solutions are scalable, sustainable and robust.You will also lead team development and cross team relationships and delivery to advance the company's engineering delivery.Responsibilities:Lead a local or regional team of engineering professionals that design, develop, deploy and enhance new and existing data centric products or solutions through the use of modern platforms and technologies.Provide routine inputs and guidance to the data engineering team on business requirements analysis, technical specification's preparation, product delivery, testing and operation to support businesses strategic direction.Coach engineers, share relevant technical approaches, identify new trends, modern skills and present new methodologies within the data engineering community.Lead and develop a team, coach and make decisions related to talent management, hiring, performance, and disciplinary actions.Other duties as assignedRequirements:Minimum QualificationsBachelor's degree in a related field or equivalent experience.Minimum of four years of related work experience.Minimum of two years leading a team of Data Engineers.Preferred QualificationsConfirmed data engineering experience with data storage and management of large, heterogenous datasets, including formats, structures, and cataloging with such tools as Iceberg, Parquet, Avro, ORC, S3, HFDS, HIVE, Kudu or others.Experience leading Big Data engineering teams working in environments such as Hadoop and SparkExperience leading technology strategies with cloud Platforms including AWS, GCP or AzureExperience leading engineering teams working in streaming and stream integration or middleware platforms, tools, and architectures such as Kafka, Flink, JMS, or Kinesis.Confirmed knowledge of best practice patterns and how to apply them to modern data architectures, including data warehouses, data lakes, data mesh, hubs and associated capabilities including ingestion, governance, modeling, observability and more.Experience leveraging transformation and modeling tools, including SQL based transformation frameworks, orchestration and quality frameworks including dbt, Apache Nifi, Talend, AWS Glue, Airflow, Dagster, Great Expectations, Oozie and others.Strong programming knowledge of SQL, Python, R, Java, Scala or equivalent.Proficiency in engineering tooling including docker, git, and container orchestration services.Strong experience leading devops teams with demonstratable understanding of associated best practices for code management, continuous integration, and deployment strategies.Experience and knowledge of data governance considerations including quality, privacy, security associated implications for data product development and consumption.A passion for quality and continuous improvement with an owners mindset.Ability to work effectively as part of a team, group and cultureAbility to navigate ambiguity and work in agile ways.

Responsibilities:The Chemist I, under direct supervision, learns and performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation.May participate in investigations.Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing.Conducts routine laboratory analyses: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing.Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Uses laboratory software for analyses.Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeepingCleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.Under close supervision, learns to troubleshoot basic instrument problems.With guidance, participates in OOS/OOT/NOE and other investigations.Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor.May assist in drafting, editing, and reviewing SOPs and laboratory investigations.Maintains assigned training records current and in-compliance.May assist in the training of less senior laboratory staff.Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.Follows internal processes related to controlled substances continuous.Follows EH&S procedures to ensure a safe work environment.Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS continuous.Requirements:Minimal acceptable level of education, work experience and certifications required for the job.Bachelor of Science Degree in chemistry, chemical engineering or related field with analytical chemistry coursework required. Some pharmaceutical laboratory experience preferred.Proficiency in a body of information required for the job.e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.Proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Basic knowledge of wet chemistry techniques.Knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.Competency in Microsoft Office Suite.Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.Ability to display and analyze data in a logical manner.Good verbal and written communication skills as well as good computer skills.Attention to details and accurate record keeping.Establish and maintain cooperative working relationships with othersSolid organizational skills.Ability to take initiative, set priorities and follow through on assignments.Physical & mental requirements e.g., lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicalsMust occasionally lift and/or move up to 15-25 lbs.Ability to wear personal protective equipment, including respirators, gloves, etc. Specific visions abilities are required by this job include close vision and color vision.Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.

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6 gcp Jobs found

Operations Supervisor

DevOps Engineer

Quality Control Supervisor

Associate Software Engineer - AI/ML systems Gurugram/New York

Data Engineer / Senior / Supervisor

QC Chemist I

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Operations Supervisor

DevOps Engineer

Quality Control Supervisor

Associate Software Engineer - AI/ML systems Gurugram/New York

Data Engineer / Senior / Supervisor

QC Chemist I

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