Piramal Pharma Solutions
Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.
This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.
Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
Job Title
Chief Manager - Quality Assurance
Job Description:
This role is Responsible for ensuring compliance with cGMP guidelines in the manufacturing and quality control. The role includes approving quality procedures, specifications, and batch records,
as well as reviewing QMS elements such as Change Control, Deviation, CAPA, OOS/OOT, complaints, returns, and recalls. The incumbent will also ensure proper investigation and closure of quality issues, conduct internal audits, and perform vendor evaluation for raw and packaging materials to maintain quality standards.
- Release or rejection of all APIs.
- Establishment of system as per CGMP to release or reject raw materials, intermediate packaging and labelling materials.
- Approving all procedures impacting the quality of intermediates or APIs.
- Review & approval of the QMS elements like Change Control. Deviation, CAPA, OOT, Customer Complaint, Return Goods & Recall.
- Final review and authorization of completed batch production laboratory control record before release of the API for distribution.
- Ensure all deviations, OOS, OOT are properly investigated and closed.
- Approving all specifications and master pr