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.
- Solid 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

Education:

- B. Pharm B. Pharm - Required

- M. Pharm M. Pharm - Preferred

Experience:

- 2 years or more in 2 - 5 Years

Specialized Knowledge: Licenses:

📌 Executive, QA Validation (India)
🏢 Amneal Pharmaceuticals
📍 India