Sterile Injection Quality Assurance Expert

1 week ago

Rajahmundry, Andhra Pradesh, India beBeeCompliance Full time ₹ 20,00,000 - ₹ 40,00,000

Quality Assurance Specialist

Job Description:

  • Manufacturing Oversight: Ensure completeness, accuracy, and compliance with cGMP, SOPs, and regulatory requirements for executed Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs).
  • Coordinate with on-site teams to resolve discrepancies or missing documentation before batch release.
  • Monitor In-Process Control Data: Review electronic in-process control (IPC) data, critical process parameter logs, and environmental monitoring results uploaded from the site.
  • Verify Product Labels: Check 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 remote review summaries for cross-functional teams.
  • Assess Change Control Proposals: Evaluate potential impacts on validation, processes, and regulatory compliance for electronic change control proposals via QMS software.
  • 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 (OOS) and Out-of-Trend (OOT) investigation reports submitted from the site, ensuring thorough root cause analysis and effective preventive measures.
  • Ensure Remote Audit Readiness: Review documentation for alignment with cGMP, US FDA, and other applicable regulatory requirements.

Key Skills and Competencies:

  • 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 and Qualifications:

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

This role offers the opportunity to work in a dynamic environment, collaborating with cross-functional teams to drive quality and compliance. If you have expertise in validation, aseptic techniques, and regulatory guidelines, this is an excellent chance to leverage your skills and contribute to our organization's success.

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