Sterile Injectable Manufacturing Process Specialist

4 days ago

Nagpur, Maharashtra, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Job Title: Process Quality Assurance Specialist

This is a challenging role that requires strong analytical and problem-solving skills to ensure the quality of manufacturing processes.

  • Manufacturing Oversight
  • Review and approve Batch Manufacturing Records (BMRs) for completeness, accuracy, and compliance with cGMP, SOPs, and regulatory requirements.
  • Coordinate with on-site teams to resolve discrepancies or missing documentation before batch release.
  • Review electronic in-process control (IPC) data, critical process parameter logs, and environmental monitoring results uploaded from the site.
  • Verify product label templates, proofs, and electronic versions for accuracy against specifications and regulatory standards.
  • Compile, review, and analyze electronic data for Annual Product Quality Review (APQR) reports, identify trends or recurring issues, and prepare summaries for cross-functional teams.
  • Review, assess, and approve electronic change control proposals via QMS software, evaluating potential impacts on validation, processes, and regulatory compliance.
  • Conduct remote review of deviation reports, root cause analyses, and corrective action proposals, and track deviation trends for periodic reporting.
  • Approve CAPA plans in the QMS system, ensuring they address identified issues with measurable effectiveness criteria, and review closure documentation to confirm adequacy of evidence.
  • Review and approve Out-of-Specification (OOS) investigation reports submitted from the site, ensuring thorough root cause analysis and effective preventive measures.
  • Ensure audit readiness by reviewing documentation for alignment with cGMP, US FDA, and other applicable regulatory requirements.
  • Participate in virtual inspections and audits, providing requested documentation and clarifications.
  • Maintain close coordination with on-site QA personnel to ensure timely resolution of documentation and compliance issues.
  • Provide remote guidance to manufacturing site teams through virtual meetings and written communication.

Key Skills and Competencies:

  • Expertise in manufacturing processes and quality assurance techniques.
  • In-depth knowledge of 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.

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