Officer/Trainee - MS&T

Job Title:

Trainee/Officer - MS&T / Technology Transfer to support the successful transfer of new products from R&D to the manufacturing site. The role involves coordination of scale-up and exhibit batches, documentation preparation, technical support during execution, and collaboration with various departments to ensure timely and smooth product introduction and regulatory compliance.

Key Responsibilities:

• Coordinate the transfer of products from R&D to the manufacturing site.
• Review and finalize technology transfer documents from R&D and external partners.
• Liaise with site teams to ensure readiness and approval of all TT documents.
• Identify and address technical gaps for smooth new product introduction.
• Prepare and review batch records, protocols, and reports for scale-up batches.
• Monitor and provide technical support during execution of scale-up and exhibit batches.
• Support the regulatory team by providing required documentation for product filings.
• Ensure availability of all required materials (API, raw materials, packaging, consumables).
• Oversee sampling and stability testing as per approved protocols.
• Prepare and review SOPs; ensure compliance with cGMP guidelines.
• Assist production and quality teams during batch execution activities.
• Support Quality Management System (QMS) activities including deviations, CAPAs, and change controls.

Qualification, Experience and Skills required:

• B.Pharm / M.Pharm / M.Sc. with 03 years in pharmaceutical manufacturing, Technology Transfer or MS&T
• Experience in batch record preparation, production compounding, and IPQA batch monitoring.
• Familiarity with R&D development activities.
• Strong cross-functional coordination and communication skills.

Understanding of regulatory and GMP requirements.