Manufacturing Compliance Specialist

5 days ago

Tiruppur, Tamil Nadu, India beBeeCompliance Full time ₹ 40,00,000 - ₹ 60,00,000

Our organization is seeking a highly skilled Manufacturing Compliance Specialist to join our team. In this role, you will play a critical part in ensuring that our manufacturing processes meet the highest standards of quality and regulatory compliance.

About the Role

As a key member of our team, you will be responsible for reviewing and approving Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs) to ensure completeness, accuracy, and compliance with cGMP and regulatory requirements.

  • Coordinate with on-site teams to resolve discrepancies or missing documentation before batch release.
  • Review electronic in-process control (IPC) 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 (APQR) 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 (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 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.
Key Skills and Qualifications

To succeed in this role, you will require:

  • 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.
What We Offer

We offer a dynamic and supportive work environment, where you can grow your career and contribute to our mission. If you are passionate about manufacturing compliance and regulatory affairs, we encourage you to apply for this exciting opportunity.

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