Senior Quality Assurance Specialist

2 days ago

Madurai, Tamil Nadu, India beBeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

As a critical member of our quality assurance team, you will play a pivotal role in driving the highest standards of excellence and compliance within our manufacturing processes.

Responsibilities:

  • Verify and authenticate executed batch manufacturing records (BMRs) and batch packaging records (BPRs) to ensure accuracy and adherence to regulatory guidelines.
  • Collaborate with on-site teams to resolve discrepancies or missing documentation before batch release.
  • Analyze electronic data for trends or recurring issues and prepare review summaries for cross-functional teams.
  • Assess electronic change control proposals via QMS software to evaluate potential impacts on validation and regulatory compliance.
  • Conduct reviews of deviation reports, root cause analyses, and corrective action proposals, and track deviation trends for periodic reporting.
  • Approve CAPA plans in the QMS system to ensure they address identified issues with measurable effectiveness criteria.
  • Review and verify Out-of-Specification (OOS) and Out-of-Trend (OOT) investigation reports submitted from the site.

Requirements:

  • In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques is required.
  • Expertise in validation methodologies and regulatory guidelines is essential.
  • Strong analytical and problem-solving skills are necessary for success.
  • Effective communication and documentation skills are vital for this role.
  • Ability to manage cross-functional teams and prioritize tasks is crucial.
Benefits

This role offers opportunities for professional growth and development, as well as a chance to make a meaningful impact on our company's success.

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