Job Description Manager (QA & QC)
Position Title: Manager QA & QC
Department: QA & R&D;
Reports To: General Manager / Senior Manager
Role Overview
The Manager (QA & QC) will lead the Quality Assurance and Quality Control functions, ensuring
compliance with regulatory standards and supporting manufacturing excellence. This role involves
managing laboratory operations, supervising chemists, maintaining equipment, and providing
technical expertise to resolve deviations and quality issues.
Key Responsibilities
1. Laboratory Operations
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Direct day-to-day QA/QC laboratory activities, including chemists supervision and
equipment maintenance.
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Execute laboratory testing of raw materials and finished batch samples.
2. Data Review & Analysis
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Review and compile laboratory test data.
Perform appropriate statistical and trend analysis.
3. Deviation & Compliance Management
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Investigate manufacturing deviations (e.g., OOS).
Prepare deviation documentation, investigational reports, change control, and CAPA.
4. Documentation Control
Write, review, and approve technical reports, SOPs,
laboratory protocols, and trend
analyses.
5. Technical Support & Troubleshooting
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Identify and resolve gaps in processes.
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Provide technical support for equipment issues, quality complaints, and other
operational challenges.
6. Facility & Equipment Maintenance
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Ensure routine housekeeping, lab inventory management, and equipment cleaning.
Support pharmaceutical manufacturing facility upkeep.
7. Team Development
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Contribute to team building, training programs, and problem-solving initiatives.
Mentor and professionally develop analysts to enhance performance.
8. Cross-Functional Communication
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Collaborate effectively with QA, manufacturing, and process development teams.
9. Customer Complaint Handling
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Review customer complaints.
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Monitor and implement corrective and preventive actions (CAPA).
10. Audit Participation
Represent QA/QC during customer quality audits and manufacturing facility
inspections.
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