Roles and Responsibilities
- Ensure compliance with cGMP regulations and company policies during BMR reviews.
- Implement change controls by reviewing CAPAs, conducting audits, and ensuring timely closure.
- Prepare for OSD inspections by gathering relevant documents and providing training to team members.
- Collaborate with cross-functional teams to resolve quality issues and improve processes.
- Conduct BPR review meetings, including preparation of agendas, minutes, and follow-up on action items.
Desired Candidate Profile
- Solid understanding of BPR review, Change Control, Cleaning Validation, Equipment Qualification, GMPs/cGMPs principles.
- 3-8 years of experience in IPQA or related field (B.Pharma + M.Pharma).
- Excellent communication skills for effective collaboration with stakeholders.
- Ability to work independently with minimal supervision while maintaining high standards of accuracy.