Description:
The position is responsible for leading in-process and final product quality analyses and inspections in compliance with regulatory requirements and internal quality standards. The role focuses on interpreting and evaluating analytical results to ensure accuracy, precision, and adherence to established specifications. The role proactively identifies ongoing quality issues, prevents potential production and compliance risks, and recommends continuous improvement initiatives. The position ensures effective use of measuring devices, testing equipment, validated methods, and predefined procedures to accept or reject products. As a people leader, the role audits and monitors manufacturing processes, oversees random testing of finished goods, and ensures timely reporting and resolution of deviations and defects.
Essential Functions:
- Lead in-process, finished product, and release testing activities
- Interpret and evaluate analytical data against approved specifications
- Identify recurring quality issues and prevent potential production risks
- Ensure correct use of analytical instruments, methods, and procedures
- Approve or reject materials and products based on QC outcomes
- Audit and monitor manufacturing processes and quality outputs
- Review and approve analytical data, COAs, and QC documentation
- Lead deviation, OOS/OOT investigations and CAPA implementation
- Ensure readiness for internal, external, and regulatory audits
- Drive continuous improvement across QC systems and processes
Mentor, develop, and lead QC managers and laboratory teams
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Additional Responsibilities:
- Lead and oversee all Quality Control laboratory activities including Wet Laboratory, Instrumentation, Stability, and Microbiology (if applicable).
- Ensure timely testing and release of Raw Materials, Intermediates, Finished Products, Stability Samples, and Cleaning Validation Samples.
- Review and approve analytical data, certificates of analysis, specifications, methods, protocols, and reports.
- Ensure compliance with cGMP, GLP, GDP, Data Integrity, and regulatory requirements.
Drive investigations related to OOS, OOT, Deviations, Laboratory Incidents, Market Complaints, and CAPA implementation.
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- M.Sc. (Chemistry/Analytical Chemistry/Organic Chemistry) / B.Pharm / M.Pharm
- Strong understanding of cGMP, GLP, GDP, and Data Integrity requirements.
