10 - 17 years
11 - 17 Lacs
Posted:2 days ago|
Platform:
Work from Office
Full Time
Job Profile:
Tech Transfer Execution:
Coordinate and lead tech transfer of sterile injectable drug products (vials, prefilled syringes, ampoules, etc.) across internal or external manufacturing sites.
Process Understanding:
Analyze process development data, define critical process parameters (CPPs), and assess impact on manufacturing performance.
Prepare and review technology transfer protocols, risk assessments, reports, batch records, and process flow diagrams.
Scale-Up Support:
Collaborate with process development, formulation, and manufacturing teams to ensure robust process scale-up and validation.
Work closely with QA, QC, Regulatory Affairs, Validation, and Engineering to support all aspects of tech transfer and process validation.
Troubleshooting:
Provide technical support for deviations, investigations, and change controls related to injectable manufacturing.
Compliance:
Ensure all activities adhere to cGMP standards, internal SOPs, and applicable regulatory guidelines (FDA, EMA, etc.).
Continuous Improvement:
Identify opportunities for process optimization and efficiency in tech transfer projects.
Thanks & Best Regards
Team Jodas Expoim
Jodas Expoim
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