Pharmaceutical Manufacturing Specialist

2 weeks ago

Shimoga, Karnataka, India beBeeManufacturing Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

As a seasoned manufacturing specialist, you will play a pivotal role in ensuring the quality of pharmaceutical products meets regulatory requirements and industry standards. Your expertise will be crucial in reviewing executed Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs), coordinating with on-site teams to resolve discrepancies, and verifying product label templates for accuracy.

Key Responsibilities:
  • Review and approve electronic in-process control (IPC) data, critical process parameter logs, and environmental monitoring results to ensure compliance with current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs).
  • 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.
  • Conduct remote review of deviation reports, root cause analyses, and corrective action proposals, and track deviation trends for periodic reporting.

Our ideal candidate will possess in-depth knowledge of sterile injectable manufacturing processes and aseptic techniques, as well as expertise in validation methodologies and regulatory guidelines. Strong analytical and problem-solving skills, effective communication, and documentation skills are essential for this role. Proficiency in Quality Management Systems (QMS) tools is also required.

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

This role offers a competitive salary range and opportunities for career growth in the pharmaceutical industry. If you are a motivated and detail-oriented professional looking to make a meaningful impact, please apply.

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