Executive, QA Validation
Amneal Pharmaceuticals
JOB 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.
- 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
QUALIFICATIONS
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
- 2 years or more in 2 - 5 Years