Senior Quality Assurance Manager Position

3 days ago


India beBeeAssurance Full time ₹ 15,00,000 - ₹ 20,00,000
Quality Assurance Specialist Job

The Quality Assurance Specialist is responsible for reviewing and approving executed batch manufacturing records and batch packaging records submitted from manufacturing sites.

Key Responsibilities:
  • Review and approve electronic in-process control 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.
  • 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.
Requirements:
  • Proficiency in 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.

This is an opportunity to develop your expertise in quality assurance and contribute to a collaborative team environment.



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