Manufacturing Oversight Specialist

1 day ago


Aligarh, Uttar Pradesh, India beBeeAseptic Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Key Role in Manufacturing Oversight

The In-Process Quality Assurance specialist will be responsible for reviewing and approving executed Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs) submitted from manufacturing sites to ensure completeness, accuracy, and compliance with regulatory requirements.

They will work closely 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.

Additionally, they will 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.

Key Skills:

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

Education and Qualifications:

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


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