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1-3 years
₹3.5–5.5 LPA
10 July 29, 2025
Job Description
Job Type: Full Time Education: MSc Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.