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Manufacturing Quality Control Expert

2 weeks ago


Kottayam, Kerala, India beBeeQuality Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

Quality Assurance Specialist

  • Ensure thorough review of executed batch manufacturing records (BMRs) and batch packaging records (BPRs)
  • Coordinate with on-site teams to resolve discrepancies or missing documentation
  • Review electronic in-process control (IPC) data, critical process parameter logs, and environmental monitoring results
  • Verify product label templates, proofs, and electronic versions for accuracy against specifications
  • Compile, review, and analyze electronic data for annual product quality review (APQR) reports
  • Review, assess, and approve electronic change control proposals via QMS software
  • Conduct remote review of deviation reports, root cause analyses, and corrective action proposals
  • Approve CAPA plans ensuring they address identified issues with measurable effectiveness criteria
  • Review and approve out-of-specification (OOS) and out-of-trend (OOT) investigation reports submitted from the site
  • Ensure remote audit readiness by reviewing documentation for alignment with cGMP and regulatory requirements

Required Skills:

  • Expertise in validation methodologies and regulatory guidelines
  • Strong analytical and problem-solving skills
  • Effective communication and documentation skills
  • Ability to manage cross-functional teams and prioritize tasks
  • Proficiency in QMS tools and software

Education and Qualifications:

  • Bachelor's/Master's degree in pharmacy, biotechnology, microbiology, or related field