Manufacturing Quality Assurance Specialist

5 days ago

Anand, Gujarat, India beBeeQuality Full time ₹ 20,00,000 - ₹ 25,00,000
Manufacturing Quality Assurance Specialist

We are seeking a detail-oriented Manufacturing Quality Assurance Specialist to join our team. As a key member of our quality assurance department, you will play a vital role in ensuring the highest standards of quality and compliance in our manufacturing processes.

Responsibilities:
  • Review and Approval: Review and approve executed batch manufacturing records (BMRs) and batch packaging records (BPRs) submitted from manufacturing sites to ensure completeness, accuracy, and compliance with cGMP, SOPs, and regulatory requirements.
  • Discrepancy Resolution: Coordinate with on-site teams to resolve discrepancies or missing documentation before batch release.
  • Electronic Data Review: Review electronic in-process control (IPC) data, critical process parameter logs, and environmental monitoring results uploaded from the site.
  • Product Label Verification: Verify product label templates, proofs, and electronic versions for accuracy against specifications and regulatory standards.
  • APQR Report Analysis: Compile, review, and analyze electronic data for Annual Product Quality Review (APQR) reports, identify trends or recurring issues, and prepare remote review summaries for cross-functional teams.
  • Change Control Evaluation: Review, assess, and approve electronic change control proposals via QMS software, evaluating potential impacts on validation, processes, and regulatory compliance.
  • Deviation Review: Conduct remote review of deviation reports, root cause analyses, and corrective action proposals, and track deviation trends for periodic reporting.
  • CAPA Plan Approval: Approve CAPA plans in the QMS system, ensuring they address identified issues with measurable effectiveness criteria, and review CAPA closure documentation to confirm adequacy of evidence.
  • OOS/OOT Investigation: Review and approve Out-of-Specification (OOS) and Out-of-Trend (OOT) investigation reports submitted from the site, ensuring thorough root cause analysis and effective preventive measures.
  • Audit Readiness: Ensure remote audit readiness by reviewing documentation for alignment with cGMP, US FDA, and other applicable regulatory requirements.
  • Virtual Inspections: Participate in virtual inspections and audits, providing requested documentation and clarifications.
Requirements:
  • Education: Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.
  • Skills: In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques; expertise in validation methodologies and regulatory guidelines (US FDA, cGMP etc.); 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.

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