Executive - CQA

4 days ago

Navi Mumbai, Maharashtra, India Lupin Full time ₹ 6,00,000 - ₹ 18,00,000 per year

Job Description

JOB Responsibilities: -

Location: Ahmedabad

  1. Ensuring the GMP compliance at CMO and Release of batch manufactured for US market at CMU.
  2. Monitoring of process starting from dispensing to packing including witness analysis of Lupin products manufactured at CMO for US market and Domestic market.
  3. Handling of market complaint with root cause identification and ensuring the CAPA implementation.
  4. New product review to be carried out at manufacturing site after availability of all the documents.
  5. Review and authorize Master Batch Records, stability protocol, process validation protocol, temperature cycling protocol, specification of in-process, intermediate and finished products at CMU.
  6. Review of documents such as executed Batch Production Records, Analytical records, Change Controls, Deviations, OOS, Process Validation, Cleaning Validation, Equipment Qualification, stability data and CAPA for Lupin products manufactured at CMU.
  7. Provide required documents to Regulatory affairs for variations and updates.
  8. Review & follow-up for effective compliance of observations made during day-to-day activities and audits conducted by CQA team.
  9. Review & implementation of Pharmacopeial changes of products manufactured at CMU.
  10. Routine / new site audit of CM location delegated by the Appraiser & prepare audit reports, review of compliance and ensure the closer of CAPA.
  11. Implementation of corporate CAPAs across CMO locations.
  12. Ensuring process and packing validation, stability and transport validation (wherever applicable) of new products.
  13. Ensuring the implementation of quality agreements clauses at CMO.
  14. Additional responsibilities assigned by reporting's as per time to time requirements.

Work Experience

8 to 10 years

Education

Graduation in Pharmacy

Competencies

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