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.
* Solid Project Management Skills

📌 Executive, QA Validation (Ahmedabad)
🏢 Amneal
📍 Ahmedabad