Team member MSAT injectable

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