Senior Sterile Manufacturing Specialist

5 days ago

Varanasi, Uttar Pradesh, India beBeeSTERILE Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

Job Overview:

  • In this role, you will be responsible for ensuring the highest standards of quality and compliance in our manufacturing processes.

Key Responsibilities:

  • Manufacturing Oversight:
    • Review and approve executed batch manufacturing records (BMRs) and batch packaging records (BPRs) to ensure completeness, accuracy, and compliance with cGMP, SOPs, 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.
  • Quality Analysis and Reporting:
    • 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.
  • Documentation and Compliance:
    • 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.

Requirements:

  • 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.

Education and Qualifications:

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

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