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.
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.
Participate in cross-functional quality improvement projects.
Support cleaning validation, analytical method validation, and computerized system validation where applicable.
Additional Skills :
Job details are sourced from the employer's original posting.
Open job postingAbout the company
Amneal India is a pharmaceutical company focused on developing, manufacturing, and marketing high-quality generic and specialty pharmaceutical products.