Manager - QC
Global Calcium Pvt. Ltd. 4.9
General
Work from Office
1
Any
Not Required
No
Job Description
Lead work planning and daily task allocations for QC analysts to ensure smooth laboratory workflow.
Review analytical raw data, test results, and stability reports of raw materials, in-process, and finished products with complete audit trails.
Oversee QMS activities including laboratory incidents, change controls, out-of-specification (OOS) investigations, and process deviations.
Take end-to-end responsibility for stability studies from sample inception to final data compilation and approval.
Review Certificate of Analysis (CoA) records inline with internal and customer specifications.
Coordinate with external testing laboratories, review third-party analysis reports, and manage AR&D analytical method transfers.
Plan method verifications against monograph standards and ensure strict compliance with cGMP, GLP, and regulatory requirements.
Guide QC analysts, lead capability development training, and manage regulatory/customer quality audits.
Contact Details for Application:
Email: mounika.d@globalcalciumpharma.com
Qualifications
M.Sc Chemistry.
10 – 15 Years of extensive Quality Control management experience in the pharmaceutical API / chemical manufacturing sector.
Expertise in lab QMS, analytical method validation/transfers, stability studies, instrument audit trails, and regulatory inspections.