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Quality Control Associate - Supervisor
Dr Reddy's Laboratories Limited
Hyderabad, IND
Full-time
Mid-Senior
Onsite
Discovered 1 weeks ago
Quality control laboratory operationsCurrent Good Manufacturing Practice (cGMP)Safety, Health and Environment (SHE) complianceAnalytical method validationTechnology transfer of analytical methodsQuality management systems
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Quality control laboratory operationsCurrent Good Manufacturing Practice (cGMP)Safety, Health and Environment (SHE) compliance
Key Skills for This Role
Quality control laboratory operationsCurrent Good Manufacturing Practice (cGMP)Safety, Health and Environment (SHE) complianceAnalytical method validationTechnology transfer of analytical methodsQuality management systems
Full Job Posting
Responsibilities
- Execute planned laboratory activities in compliance with cGMP and maintain a safe work environment under SHE norms.
- Complete training requirements and method qualifications according to schedule.
- Write and review analytical method validation protocols and reports in compliance with regulatory norms.
- Prepare, execute, and review technology transfers for analytical methodologies.
- Ensure timely closure of laboratory QMS elements through thorough investigations.
- Initiate and close change controls for system improvements and new method or system implementations.
- Initiate and close deviations, OOS, OOT, incidents, and CAPA in the laboratory.
- Prepare or review SOPs, STPs, and ROAs.
- Support regulatory inspections and plan commercial release testing.
- Maintain instruments and perform routine calibration.
Qualifications
- A Bachelor’s degree in Chemical Engineering or a Master’s degree in Science.
- Six to nine years of experience working with biosimilar products.
Technical Scope
- The role requires laboratory quality control experience covering cGMP, analytical method validation, technology transfer, QMS investigations, change controls, CAPA, documentation, inspections, release testing, and calibration.
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