Manufacturing Oversight Specialist

2 days ago

Thoothukudi, Tamil Nadu, India beBeeQuality Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

Manufacturing Oversight Role

This is an exciting opportunity to lead the manufacturing oversight function in a fast-paced industry.

The successful candidate will be responsible for reviewing and approving batch manufacturing records and batch packaging records submitted from manufacturing sites to ensure completeness, accuracy, and compliance with regulatory requirements.

  • Review and Approval: The Manufacturing Oversight Specialist will execute batch manufacturing records (BMRs) and batch packaging records (BPRs) submitted from manufacturing sites to ensure completeness, accuracy, and compliance with cGMP, SOPs, and regulatory requirements.
  • Discrepancy Resolution: The specialist will coordinate with on-site teams to resolve discrepancies or missing documentation before batch release.
  • Data Review: The role involves reviewing electronic in-process control (IPC) data, critical process parameter logs, and environmental monitoring results uploaded from the site.
  • Label Verification: The Manufacturing Oversight Specialist will verify product label templates, proofs, and electronic versions for accuracy against specifications and regulatory standards.
  • APQR Analysis: The role includes 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.

Key Skills and Qualifications

  • Strong knowledge of sterile injectable manufacturing processes and aseptic techniques.
  • Expertise in validation methodologies and regulatory guidelines.
  • Excellent analytical and problem-solving skills.
  • Effective communication and documentation skills.
  • Ability to manage cross-functional teams and prioritize tasks.

Education and Experience

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

Other Responsibilities

  • Approving CAPA plans ensuring measurable effectiveness criteria.
  • Reviewing deviation reports, root cause analyses, and corrective action proposals.
  • Ensuring remote audit readiness by reviewing documentation.
  • Participating in virtual inspections and audits.
  • Maintaining coordination with on-site QA personnel and providing remote guidance to manufacturing site teams.

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