Senior Sterile Operations Specialist

21 hours ago

Udaipur, Rajasthan, India beBeeQualityAssurance Full time ₹ 15,00,000 - ₹ 20,00,000
Quality Assurance Specialist

This role involves ensuring the quality of manufactured products through batch records review and approval, coordination with on-site teams, and verification of product label templates.

The ideal candidate will possess in-depth knowledge of sterile injectable manufacturing processes and aseptic techniques. Expertise in validation methodologies and regulatory guidelines is also required.

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

We are seeking an analytical and problem-solving expert who can manage cross-functional teams and prioritize tasks effectively. Proficiency in QMS tools and software is essential.

The Quality Assurance Specialist will be responsible for:

  1. Reviewing and approving executed Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs)
  2. Coordinating with on-site teams to resolve discrepancies or missing documentation
  3. Verifying product label templates, proofs, and electronic versions
  4. Compiling, reviewing, and analyzing electronic data for Annual Product Quality Review (APQR) reports
  5. Reviewing and assessing electronic change control proposals via QMS software
  6. Conducting remote review of deviation reports, root cause analyses, and corrective action proposals
  7. Approving CAPA plans in the QMS system
  8. Reviewing and approving Out-of-Specification (OOS) and Out-of-Trend (OOT) investigation reports
  9. Ensuring remote audit readiness by reviewing documentation for alignment with cGMP and US FDA regulations

Key Qualifications:

  • 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.
  • Proficiency in QMS tools and software.

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