Job Description
- Prepare, review, and approve technical protocols, reports, and product impact assessments related to product lifecycle management (LCM).
- Initiate, change controls, incidents, and risk assessments related to technology transfer activities.
- Support technology transfer activities for new products, scale-ups, line transfers, and site-to-site commercial batches for injectable products.
- Coordinate with cross-functional teams for execution and documentation of new products, scale-ups, and line or site transfers.
- Support investigations for non-conformances (Incidents, OOS, OOT, Market Complaints) through root cause analysis and impact assessments.
- Provide technical support for process changes and improvements along with addressing regulatory deficiencies and support audits to ensure timely product approvals.
- Collaborate with cross-functional teams to improve manufacturing processes
- Conduct data analysis to identify trends and opportunities for process improvement
- Assist in the implementation of process improvements and new technologies
- Ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements
Qualifications
Bachelor of Technology or Bachelor of Engineering (Chemical engineer)/Bachelor of Pharmacy/Master of Pharmacy
