15 - 20 years
12 - 19 Lacs
Posted:9 hours ago|
Platform:
Work from Office
Full Time
We are Hiring for Manager / Sr. Manager - QA (API Pharma Industry)
Designation: Manager / Sr. Manager
Division: QA
Reporting: Plant Head
Qualification: M.Sc (Chemistry)
Years of Experience: 15 yo 20 Years
CTC range: Current CTC not more than 14 to 20 Laks.
Job Locations: Chennai
No. of Positions: 1
Handling Team members to ensure Production Assurance, Engineering Assurance, IT, HR & EHS assurance.
Handling regulatory audit USFDA/ Customer audits and preparation of Compliance report with HOD and CAPA effectiveness tracking.
Preparation & Review of Site Master File, Validation Master plan & Quality Manual.
Handling of Vendor selection, Evaluation and Approval. (Vendor list, Supplier Agreement, Vendor Supplier audit).
Preparation of annual cGMP training schedule & Conducting cGMP Training programmed & review and approval of Annual Training Assessment report for the calendar year.
Preparation & review of Quality/ Technical Agreements for service providers & Customers, Audit schedule preparation & Annual performance for the service provider.
Review & Approval of Equipments (e.g. Isolator chamber Containment), Instrument Supplier Qualification & In-house Qualification document DQ, IQ, OQ & PQ.
Review of Continued process Verification & Process validation, drying validation, blending validation Protocol & Report as per the USFDA process validation guidelines.
Review & approval of Facility Qualification Documents.
Thanks
K Ganapathi
Mob No. 9600387468
BVR People Consulting
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