Description
JOB 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
QUALIFICATIONS
Education
- Bachelors Degree (BA/BS) B. Sc. - Required
- Master Degree (MS/MA) M. Sc. - Preferred
Experience:
- 8 years or more in 8 - 10 Years
Specialized Knowledge: Licenses: 
