In-Process Product Inspector

3 days ago

Thāne, Maharashtra, India beBeeQualityAssurance Full time ₹ 15,00,000 - ₹ 20,00,000
Quality Assurance Specialist Job Description

A Quality Assurance Specialist will be responsible for ensuring the quality of in-process products in a sterile injectable manufacturing environment.

  • Review and approve executed batch manufacturing records (BMRs) and batch packaging records (BPRs)
  • Coordinate with on-site teams to resolve discrepancies or missing documentation
  • Review electronic in-process control (IPC) data, critical process parameter logs, and environmental monitoring results
  • 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
  • Review, assess, and approve electronic change control proposals via QMS software
  • Conduct remote review of deviation reports, root cause analyses, and corrective action proposals
  • Approve CAPA plans in the QMS system, ensuring they address identified issues with measurable effectiveness criteria
  • Review and approve out-of-specification (OOS) and out-of-trend (OOT) investigation reports submitted from the site
  • Ensure remote audit readiness by reviewing documentation for alignment with cGMP, US FDA, and other applicable regulatory requirements
  • Participate in virtual inspections and audits, providing requested documentation and clarifications
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 and Education:
  • Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field

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