MS&T Specialist I

Job Description:

Responsibilities

• Technical documentation such as batch records, protocols, and technical reports.
• Planning, preparation, and execution of scale?up batches, transfer batches, new product launches, and validation batches with end?to?end documentation compliance.
• Coordination with cross?functional teams.
• Support to the Regulatory Affairs team by providing technical documentation and responses required for regulatory submissions and variations.
• Ensuring strict compliance with GMP guidelines, safety procedures, and regulatory requirements in all operational activities.
• Hands?on experience with TrackWise and SAP for quality events, materials, and documentation management.
• Active involvement in Change Control, Deviations, Investigations, CAPA, and Out?of?Specification (OOS) handling, including root cause analysis and closure.

Qualification & Experience

• Experience in MS&T about 3-4 years.
• Qualification : B.Pharm/M.Pharm
• Experience in:
• New submissions & launches
• Material change
• Site transfer activities
• Scale up & process validation documentation and execution.
• Handling of Trackwise & SAP.