Job
Description
Harman Finochem is looking for a skilled Technology Transfer Executive to join our team. In this role, you'll be crucial in facilitating seamless technology transfers, ensuring robust documentation, and maintaining compliance with key regulatory guidelines. If you have hands-on experience with process validation, cGMP, and possess strong analytical and communication skills, we encourage you to apply! Key Responsibilities Documentation & Compliance: Prepare and manage essential documents such as BMR (Batch Manufacturing Record), Process Validation Reports, Stability Protocols, and Sampling Plans . Initiate and ensure the proper closure of Change Controls and Deviations in accordance with GMP (Good Manufacturing Practices) . Apply good knowledge of GDP (Good Documentation Practices) . Maintain good knowledge of regulatory guidelines including SUPAC (Scale-Up and Post Approval Changes), cGMP, Compliance, ICH Q1A, Q2, Q7, Q8, Q9, A10, and Q13 . Gap Assessment: Conduct GAP assessments between sending and receiving unit equipment, instruments, and documents to identify and address discrepancies. Scale-Up/Down & Experimentation: Utilize sound Scale-up/down knowledge , including calculations, forecasting, and risk assessment. Plan and perform Lab-scale experiments . Communication & Coordination: Ensure effective communication and coordination with Cross-Functional Teams (CFTs). Software Proficiency: Demonstrate hands-on experience with Advanced Microsoft Word, PowerPoint, and Excel . Preferred Candidate Profile Experience: Must have experience in Tech Transfer Department Documentation . Education: M. Pharma in Pharmaceutics. Software Proficiency: Proficiency in MS-Word, Excel, and PowerPoint. Perks and Benefits As per Company Standards.
