Senior Officer, Quality Control
About this role
The position is responsible for in-process and final product quality analyses and inspection in compliance with established specifications, standards, and regulatory requirements. The role involves interpreting and evaluating analytical results for accuracy and precision using approved methods, calibrated instruments, and defined procedures. The role tests random samples of finished goods, audits and monitors manufacturing processes and outputs against internal and regulatory standards, and identifies ongoing quality issues to prevent potential production risks. The position supports accept/reject decisions, reports manufacturing process deviations and defects, maintains robust documentation, and contributes to continuous improvement in product quality and compliance.
Essential Functions:
- Perform In-Process Testing (IPT) and Finished Product (FP) Testing as per approved specifications
- Interpret and evaluate analytical results for accuracy, precision, and compliance
- Execute Sampling and Testing Procedures for RM/PM (Raw Material / Packaging Material)
- Review and approve Certificate of Analysis (COA) Documentation
- Conduct Review of Analytical Data (RM/PM/FG/IP/IV) and ensure data integrity
- Identify quality issues and support Change Control & Deviation Management
- Review and investigate Out-of-Specification (OOS) and OOT (Out of Trend) results
- Ensure compliance with 21 CFR Part 210 & 211 (Code of Federal Regulations – Current Good Manufacturing Practice for Drugs)
- Maintain Good Documentation Practices (GDP) and laboratory records
- Support Internal and External Audits and regulatory inspections
- Use analytical instruments and measuring devices for accept/reject decisions
- Report manufacturing deviations, defects, and improvement recommendations
Additional Responsibilities:
- To be responsible for Investigation related to LIR, deviations, OOS and OOT.
- To be responsible for Initiation of Deviations, OOS, OOAL, CRN and CAPA's.
- To be responsible for Handling of Caliber e-LIMS
- Activities other than defined in the Job responsibility are to be done as per the requirement of HOD, by following HOD's instruction and guidance.
Company at a glance
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver.
Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions.
Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam.
Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.
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