Should have good exposure in injectable manufacturing in-process. Manpower handling, Good documentation Practices, should have basic knowledge of machine , Breakdown, operation and troubleshooting during machine operation, QMS, elogbook, Audit exposure.
Ph.D. or MS in Organic chemistry or related field with 2 plus years post-Ph.D. experience and 7 plus years of post-MS experience relevant to job requirements.
GCP Subject Matter Expert, Provide independent and objective quality advice in support of clinical trial activities and in line with current standard methodology. Experience in Quality Management, Quality Assurance. pharmaceuticals
Deliver non-interventional studies, research collaborations, and investigator-initiated trials, managing spend and forecasts.
Represent Study Management operations at Therapy Area Medical Affairs Team meetings.
Manage core HEVA communication processes, templates, and products across the portfolio in accordance to the scientific and value messages aligned with Core Value Dossier, the US AMCP dossier, and HEVA contributions as appropriate to other submissions
B.Pharm / M.Pharm career in Pharma packing, Production, Quality Assurance, Quality Control. freshers or Having experience in analysis of raw materials / stability / finished product with hands on experience on HPLC and other instruments.
Keeping individual updated for all current regulatory trend and providing regulatory science awareness at organization level. Expertise in providing Regulatory strategic solutions based on experience with different regulated Agencies to come out of box thinking.