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Senior Executive, QC Investigations at Amneal India

Ahmedabad, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

28 Aug, 26

Salary

0.0

Posted On

30 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

QC Investigations, OOS Analysis, OOT Analysis, Root Cause Analysis, CAPA Management, GMP Compliance, Analytical Data Review, Change Control, Audit Trails, GDP, 21 CFR Part 210 & 211, COA Approval, Regulatory Inspections, Quality Management Systems, Laboratory Investigation, Manufacturing Process Audit

Industry

Pharmaceutical Manufacturing

Description

Description: The position is responsible for in-process and final product quality analyses and inspection in compliance with approved standards and regulatory requirements. The role involves interpreting and evaluating analytical results for accuracy and precision against established specifications. The role uses measuring devices, testing equipment, predefined methods, operations, and setups to support acceptance or rejection decisions. The position identifies ongoing quality issues, prevents potential production risks, and recommends improvements. The role audits, monitors, and determines the quality of manufacturing processes and outputs, tests random samples of finished goods, and reports manufacturing process deviations and product defects through structured investigations, ensuring robust GMP documentation, CAPA closure, and regulatory compliance. Essential Functions: * Perform Investigation Analysis for OOS, OOT, deviations, and non-conformances * Review Review of Analytical Data (RM/PM/FG/IP/IV) and instrument audit trails * Conduct Laboratory Investigation & Change Control with root cause analysis * Execute CAPA Management & Documentation and effectiveness verification * Support accept or reject decisions based on investigation outcomes * Identify recurring trends and prevent potential production issues * Perform audit, monitoring, and determination of manufacturing process quality * Ensure compliance with 21 CFR Part 210 & 211 and GMP requirements * Review and approve Certificate of Analysis (COA) Documentation * Participate in Internal and External Audits and regulatory inspections * Maintain Good Documentation Practices (GDP) across investigation records Additional Responsibilities:

Responsibilities

Responsible for performing quality analyses, inspections, and structured investigations for OOS, OOT, and deviations to ensure regulatory compliance. The role involves monitoring manufacturing processes, managing CAPAs, and reviewing analytical data to prevent production risks.