Sterile Injectables Manufacturing Specialist

4 days ago

Bengaluru, Karnataka, India beBeeManufacturing Full time ₹ 20,00,000 - ₹ 25,00,000

**Job Opportunity:**

Review and Approval of Manufacturing Records

This role involves 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.

  • 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.

**Key Skills and Competencies:**

  • 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.

**Education and Qualifications:**

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

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