Requirements:
• Bachelor’s/Master’s degree in Pharmacy, Chemistry, or related field
• Experience in Technology Transfer / Manufacturing / R&D
• Strong knowledge of cGMP and regulatory guidelines
• Excellent documentation and communication skills
Location: Gummidipoondi
Experience: 2–10 Years
Key Responsibilities:
• Review and interpret process development data and ensure seamless transfer from R&D to production
• Prepare, execute, and document Technology Transfer Protocols (TTP) and reports
• Develop and review Batch Manufacturing Records (BMR) and Batch Packing Records (BPR)
• Ensure compliance with cGMP and regulatory requirements
• Collaborate with cross-functional teams including R&D, Production, QA, and QC
• Support process scale-up and commercialization activities
• Participate in exhibit batches and validation batches
• Monitor Critical Process Parameters (CPP) and Critical Quality Attributes (CQA)
• Perform troubleshooting and root cause analysis (RCA)
• Support regulatory audits and inspections (USFDA, MHRA, etc.)