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Quality Control Manager
ConfidentialBengaluru / Bangalore2 days ago
Job descriptionReview and approve all QC-related SOPs, protocols, and reports, including : Cleaning validation protocols. CDP protocols. Analytical method validation, verification, and transfer protocols. Ensure compliance with pharmacopoeial updates and implement changes as necessary. Investigate and review Out-of-Specifications (OOS), Out-of-Trend (OOT), incidents, deviations, change controls, and market complaints. Ensure the readiness of the QC laboratory for internal, external vendor, and regulatory audits. Coordinate with external agencies for equipment maintenance and rectification as needed. Supervise and authorize procurement of chemicals, columns, reagents, and solvents for the department. Ensure compliance with 21CFR Part 11 for all QC activities. Authorize specifications and release of raw materials, packaging materials, bulk samples, intermediates, and finished products in the ERP system. Coordinate and review the analysis and results of stability studies for products. Ensure QC laboratory compliance with audit observations and regulatory requirements. Drive the effective implementation of corrective and preventive actions (CAPA) in response to audit findings. Coordinate with management and external agencies for CAPEX procurement related to laboratory equipment. Ensure timely approval and delivery of required laboratory resources to avoid operational disruptions. A collaborative and growth-oriented work environment. Competitive salary and benefits package. Opportunity to work with a reputed pharmaceutical organization committed to quality excellence.
We are looking for a dedicated and experienced Quality Control Manager / Senior Manager to lead our QC department, ensuring compliance with global quality standards and regulatory requirements.
Key Responsibilities
Department Leadership & Management
- Lead and manage the Quality Control department, assigning tasks to subordinates and monitoring performance.
- Review and approve specifications, analytical reports, and packing artworks.
- Develop and implement QC policies and processes to ensure compliance with eGMP and regulatory guidelines.
- Conduct training programs for the team on SOPs, cGLP, cGMP, and QC procedures.
Documentation & Compliance
Laboratory Operations
Material Authorization & Stability Studies
Audit & CAPA Compliance
Capex & Vendor Management
What We Offer
Skills Required
Qa, Qc, Sop, Quality System, Quality Control
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Quality Control Manager • Bengaluru / Bangalore
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