Senior Officer, Quality Control

Amneal Pharmaceuticals · Ahmedabad

Description:

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.

M.SC. With Knowledge of HPLC and LIMS, Good hand in Injectable product analysis. Knowledge of GLP and minimum five years

More jobs at Amneal Pharmaceuticals · Other jobs in Ahmedabad City