Candidate who should have good knowledge in secondary packing area, track and trace, QMS activity. Require good knowledge in Complex Skid, NDDS, Lyo, Batch Manufacturing, Aseptic PFS, Vials Liquid, Autoclave, TS.
Regulatory Submissions Prepare, submit, and manage regulatory filings for API products, including new drug applications, amendments, and variations, while ensuring compliance with relevant guidelines and regulations. API Equipment Handling.
Pre formulation studies of Pharmaceutical & Medicinal Devices and to check the compatibility of the API with different excipients. Formulation development of Pharmaceutical & Medicinal Devices. Execution of successful technology transfer at commercial site.
Manipal Academy of Higher Education an Institution of Eminence Deemed to be University invites applications from eligible candidates for faculty positions at Manipal College of Pharmaceutical Sciences, a constituent unit of MAHE, Manipal.
Responsible for execution of the study and system related activities as per the established Standard Operating Procedures, Good Clinical Practices, Good Laboratory Practices and regulatory requirements.
Skilled in process validation document preparation and review, with strong knowledge of QMS, qualification documents, regulatory audits, and vendor qualification and audits in a regulated environment.