Roles and Responsibilities: QMS (QC OOS/OOT/Lab incident)
Experience: 3 to 5 years
Education: B.Pharm / M.Pharm
No. of Position: 02
Location: Baroda
1. Must have exposure of working in a sterile manufacturing unit.
2. Must have participated in regulatory audits like USFDA, MHRA
3. Responsible for review of OOS, OOT, Lab incident and their tracking till closure
4. Responsible for review of change control, deviation, CAPA, SOP, risk assessment and other QMS document related to Quality Control department as applicable
5.Hands on experience of LIMS, Trackwise, DMS and Lonza MODA software
6 To ensure all RM, PM, in-process, finish product and stability samples analysis completed as per approved procedure.
7.To review analytical specifications, test procedures, test data sheet for raw material, packing material, intermediate, drug substance, semi-finished, finished product, stability and microbiology.
9. To review the data submitted by QC and cross check the calculations against the raw data / log book.
If interested please share your CV on rect2@saigroupbrd.com
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