He / She will be responsible for
Designing & Implementing / ensuring Compliance to Quality
, Validation System & Analytical Assurance as per USFDA Guidelines.
Handling and managing Regulatory authorities and customer audits.
Technical agreements review.
Review of QBR for ANDA filing.
Preparation, review and execution of standard operating procedures and documents.
Validations Analytical Method validation, Analytical method transfers activity. Equipment and instrument validation protocol approval and certification.
Review and approval of protocol and summary reports of compatibility study.
Review of Technical Transfer Packages / PDR of New drug molecules from R&D.
Conducting Vendor audits.
Ph.D. / M.Pharma / M.Sc. with hard core experience in QA of finished dosage form Manufacturing Company of repute having USFDA approval .