Website Zydus Group Ltd
Location – Ahmedabad Based Plant
Position – Executive /Sr. Executive
Qualification – B.Pharma/M.Pharma
Experience Required – Between 2-8 Years Of Experience
Role- Technology Transfer
Experience / Exposure in:
Must have worked in regulated plants having approvals of USFDA, MHRA. etc.
Hands-on experience in handling and implementing cGMP (Current Good Manufacturing Practice) practices and Good Documentation Practices
Job Description :
1. Responsible for Scale up, technology Transfer, exhibit batches for commercial products.
2. Site Transfer of approved products from one facility to another facility.
3. Evaluation and Selection of Optimal batch sizes for scaling up using scientific scale up techniques as guidance based on manufacturing process and equipment capacities for Registration batches and Launch commercial production.
4. Preparation and review of Master batch documents, Validation protocols and reports related to submission batches & Process validation.
5. Coordination with Regulatory, Production, PPMC, QC, QA and other functions for Technology Transfer activities.
6. Revalidation, technical trouble shooting, batch size changes & Alternate vendor development.
