Sterile Manufacturing Specialist

5 days ago

Thiruvananthapuram, Kerala, India beBeeSterilization Full time ₹ 15,00,000 - ₹ 20,00,000

Job Summary:

We are seeking a highly skilled Sterile Manufacturing Specialist to join our team. In this role, you will be responsible for ensuring the quality and compliance of sterile injectable manufacturing processes.

Key Responsibilities:
  • Review and approve executed Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs) submitted from manufacturing sites to ensure completeness, accuracy, and compliance with cGMP 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.
  • 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.
  • 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.
Required Skills and Qualifications:
  • 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.
Benefits:

This is an excellent opportunity to work in a dynamic environment and contribute to the success of our organization.

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