Technology Transfer Executive

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.