Coordinate for lab samples collection and logistics; review of lab reports and update PI. Review & implement appropriate recruitment/referral activities for active enrollment at sites.
Proven track record of leading a large, geographically diverse sales team including experience overseeing half of India - South & West with consistent performance, growth and positive P&L outcome.
Handling of medical inquiries / product quality complaints / ADR call receipt, lodging, responding and tracking of inquiries. Tracking of open inquiries and scheduling cases as needed.
Responsible for coordination with various departments like Regulatory Affairs, Manufacturing, Warehouse, Quality Assurance, Quality Control, Engineering for execution of Scale-up and Exhibit batches.
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