Contributes, with appropriate oversight, to all relevant aspects of global clinical trial activities to deliver study outcomes within schedule, budget, quality, compliance and performance standards. May lead specific aspects of global clinical trial. High quality contributions to study documents e.g. protocol, ICF, clinical sections of CTA -Clearly demonstrates Novartis Values and Behaviors i.e. Innovation, Quality, Collaboration, Performance, Courage and Integrity.
Expertise in sterile compounding processes, including CIP, SIP systems, component preparation, and sterilization. Hands-on experience In aseptic operations, media filling, sterilization processes, and area monitoring.
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.