Sterile Injectables Quality Assurance Specialist

1 day ago

Madurai, Tamil Nadu, India beBeeQuality Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Job Title: Sterile Injectables Quality Assurance Specialist

Key Responsibilities:

  • Review and approve batch manufacturing records to ensure completeness, accuracy, and compliance with regulatory requirements.
  • Coordinate with cross-functional teams to resolve discrepancies or missing documentation before batch release.
  • Review electronic in-process control data, critical process parameter logs, and environmental monitoring results for quality assurance.
  • 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 reports, identify trends or recurring issues, and prepare summaries for cross-functional teams.
  • Review, assess, and approve 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 CAPA closure documentation to confirm adequacy of evidence.
  • Review and approve out-of-specification and out-of-trend investigation reports submitted from the site, ensuring thorough root cause analysis and effective preventive measures.
  • Ensure remote audit readiness by reviewing documentation for alignment with cGMP 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.
Required Skills and Qualifications:
  • Strong knowledge of sterile injectable manufacturing processes and aseptic techniques.
  • Expertise in validation methodologies and regulatory guidelines (US FDA, etc.).
  • Excellent 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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