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 Positive 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'

📌 Senior Officer, SETE- Quality Control (India)
🏢 Amneal
📍 India