IPQA-Biosimilar

3 days ago

Pune, Maharashtra, India MJ Biopharm Full time ₹ 15,00,000 - ₹ 25,00,000 per year
  • Comprehensive knowledge of large-scale biotech manufacturing, covering both upstream ( fermentation) and downstream (purification ) processes.
  • Excellence in documentation for batch records and process-related documents to ensure accuracy, traceability, and regulatory compliance.
  • Proficient in cell bank management, including creation, storage, monitoring, and traceability for consistent production performance.
  • Advanced understanding of Good Manufacturing Practices (GMP), regulatory standards (including FDA), and pharmacopeial requirements for biotech products.
  • Strong communication, teamwork, and interpersonal skills to foster effective cross-functional collaboration and timely resolution of production quality issues.
  • Skilled in identifying, documenting, and investigating deviations, as well as executing root cause analysis and implementing corrective and preventive actions (CAPA).
  • Knowledge of process validation and preparation of Annual Product Quality Review (APQR) to ensure robust and compliant manufacturing operations.

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