Manufacturing Quality Assurance Specialist

2 days ago

Aurangabad, Maharashtra, India beBeeSterileInjectables Full time ₹ 18,00,000 - ₹ 24,00,000

Job Summary:

This role involves overseeing the manufacturing process to ensure quality and compliance with regulatory requirements.

The ideal candidate will have a strong background in sterile injectable manufacturing processes, aseptic techniques, validation methodologies, and regulatory guidelines.

Key Responsibilities:

  • Review and approve executed batch manufacturing records and batch packaging records to ensure 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 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 reports, identify trends or recurring issues, and prepare remote review 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 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, US FDA, and other applicable regulatory requirements.
  • Participate in virtual inspections and audits, providing requested documentation and clarifications.

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.

Education:

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

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