To have knowledge of ICH guidelines and other regional regulatory requirements including USFDA, EMA, NMPA, TGA, CADIFA and other global regulatory market.
Monitor and supervise production process to ensure compliance with SOP and cGMP. Maintain documentation as per regulatory authorities requirement like change control, deviations.
To support for commercial troubleshooting/remediation/Market complaints for Non-Oral manufacturing sites.
To support for timely investigation/execution and to resume commercial manufacturing and to meet market/ sales requirement.
Master of Pharmacy Participation in Investigations, Root cause analysis and proposing relevant CAPAs against OOS: OOT: incident, and change control complaints and audit observations to QMS team.
Sun Pharma invites positions in Pharmacokinetics. Literature search and study designing of Bioavailability and Bioequivalence studies of oral & non-oral products towards different regulatory submission.
Preparation of registration strategy for Brazil submission. Prepare response to deficiency letter received from Anvisa, Brazil. Sun Pharma, Executive Regulatory and Business Continuity