To ensure compliance of computerized systems, PLC, SCADA-controlled equipment, and automation systems with regulatory requirements 21 CFR Part 11, EU Annex 11, GAMP 5, etc. by executing validation activities as per approved procedures and maintaining validated states throughout the system lifecycle.
B.Pharm, M.Pharm ; Granulation, Compression, Coating, FBE, Capsule Hard Gelatin and Soft Gelatin, Blister Packing Primary and secondary for Cytotoxic, Sex Hormones
The research we do and the products we develop improve outcomes for patients around the world. As a Research Associate - F&D at Baxter, your work contributes directly to making a significant impact on others. It's exciting work and you're not on your own.
Prepare and review continued process verification reports for ongoing commercial products and communicate risks for taking appropriate measures for mitigation. Maintain timeline for completion of the reports along with approval.
Candidate should have experience in - Executing CAR-T cell production at lab scale and / or clinical / commercial scale including isolation of T cells, activation and transduction etc.