Executive, QA Validation
Amneal Pharmaceuticals · Ahmedabad
Description:
Prepare and review qualification protocols and reports for equipment, utilities, and systems (DQ, IQ, OQ, PQ, as applicable).
Coordinate and monitor qualification activities with Engineering, Production, and Validation teams.
Ensure qualification documentation complies with GMP and regulatory requirements. Maintain qualification schedules and ensure periodic requalification is completed on time.
- Conduct quality risk assessments using tools such as FMEA, HACCP, or risk matrices.
- Identify potential quality risks and recommend appropriate mitigation strategies.
Ensure risk management documentation is maintained and periodically reviewed.
Draft, review, revise, and maintain Standard Operating Procedures (SOPs), work instructions, protocols, and quality documents.
Ensure document control procedures are followed throughout the document lifecycle.
Coordinate periodic review of controlled documents.
Provide training on new or revised SOPs and maintain training records.
- Identify opportunities for process improvement and quality enhancement.
- Support implementation of quality metrics and trend analysis.
Participate in cross-functional quality improvement projects.
- Develop and review process validation protocols, reports, and validation master plans.
- Coordinate execution of process validation activities with cross-functional teams.
- Evaluate validation data and ensure processes consistently meet predefined acceptance criteria.
Support cleaning validation, analytical method validation, and computerized system validation where applicable.
Additional Skills :
- Knowledge of GAMP 5 and 21 CFR Part 11.
- Strong Understanding of ALCOA+ principles.
- Performing risk assessments using tools like FMEA, HACCP, and risk matrices.
- Hands-on experience with IQ, OQ, PQ, and requalification of manufacturing and laboratory equipment.
- Strong Project Management Skills
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