Quality Assurance Specialist

1 day ago

India beBeeQuality Full time ₹ 15,20,000 - ₹ 20,30,000

Job Title: Quality Assurance Specialist

We are seeking a detail-oriented and organized Quality Assurance Specialist to join our team. The ideal candidate will have a strong understanding of sterile injectable manufacturing processes, validation methodologies, and regulatory guidelines.

Responsibilities include reviewing and approving executed Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs), coordinating with on-site teams to resolve discrepancies or missing documentation, reviewing electronic in-process control (IPC) data, critical process parameter logs, and environmental monitoring results, verifying product label templates, proofs, and electronic versions for accuracy against specifications and regulatory standards, compiling, reviewing, and analyzing electronic data for Annual Product Quality Review (APQR) reports, identifying trends or recurring issues, and preparing remote review summaries for cross-functional teams, reviewing, assessing, and approving electronic change control proposals via QMS software, evaluating potential impacts on validation, processes, and regulatory compliance, conducting remote review of deviation reports, root cause analyses, and corrective action proposals, tracking deviation trends for periodic reporting, approving CAPA plans in the QMS system, ensuring they address identified issues with measurable effectiveness criteria, reviewing CAPA closure documentation to confirm adequacy of evidence, reviewing and approving Out-of-Specification (OOS) and Out-of-Trend (OOT) investigation reports submitted from the site, ensuring thorough root cause analysis and effective preventive measures, ensuring remote audit readiness by reviewing documentation for alignment with cGMP, US FDA, and other applicable regulatory requirements, participating in virtual inspections and audits, providing requested documentation and clarifications, maintaining close coordination with on-site QA personnel to ensure timely resolution of documentation and compliance issues, providing remote guidance to manufacturing site teams through virtual meetings, calls, and written communication.

Requirements:

  • 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.

Qualifications:

  • Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.

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