Executive – Quality Control (Insulin)
Location: India
Company: Biocon Biologics Limited
Department: QC Insulin
Job ID: 19660
Employment Type: Full-Time
Estimated Salary: ₹3.5–5.5 LPA (based on experience and industry standards)
Role Summary:
Biocon Biologics is seeking an Executive for the Quality Control – Insulin division to ensure compliance with cGMP/cGLP standards and manage testing, documentation, equipment calibration, and analytical activities related to insulin and medical device quality control operations.
Key Responsibilities:
Quality Systems & Compliance:
Ensure adherence to cGMP and cGLP regulations across all laboratory practices.
Monitor and maintain traceability of reserve and stability samples.
Record and report OOS (Out-of-Specification), incidents, and deviations.
Ensure compliance with EHS (Environment, Health & Safety) management systems.
Testing & Documentation:
Conduct inspections and testing of in-process, finished product, and stability samples.
Collect samples, perform analytical testing, and issue test reports as per SOPs.
Prepare and review product specifications, analytical reports, and quality records.
Support corrective and preventive action (CAPA) implementation as needed.
Maintain analytical documentation and coordinate cross-functionally.
Instrumentation & Calibration:
Handle qualification documents: URS, DQ, IQ, OQ, PQ for laboratory instruments and software.
Perform calibration and maintenance of laboratory equipment and HPLC columns.
Conduct Excel sheet validation related to testing records.
Stability & Device Analysis:
Conduct temperature and humidity mapping for stability chambers.
Analyze samples related to finished products, medical devices, validations, and stress studies.
Sample and test incoming medical device components.
QMS & Process Improvement:
Initiate QMS documents including deviations, CAPAs, incidents, specifications, and change controls.
Participate in periodic review and quality risk assessments.
Collaborate effectively with cross-functional teams to maintain quality standards.
Candidate Profile:
Education: M.Sc. in Chemistry, Biotechnology, or a related discipline.
Experience: 1 to 3 years in a Quality Control role, preferably in a pharmaceutical or biopharmaceutical setup.
Proficiency in analytical techniques and regulatory compliance.
Strong understanding of equipment qualification, documentation, and lab standards.
Good interpersonal and coordination skills with cross-functional teams.
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