Quality Assurance Manager

3 days ago


Bengaluru, Karnataka, India beBeeCompliance Full time ₹ 8,00,000 - ₹ 12,00,000

Job Title: Quality Assurance Manager

About this role

We are seeking an experienced Quality Assurance Manager to join our team. In this role, you will be responsible for ensuring compliance with regulatory requirements and overseeing the quality performance of our contract manufacturing organization.

Key Responsibilities
  • Supporting and participating in regulatory agency inspections and third-party audits at contract manufacturing organization.
  • Establishing quality performance indicators (QPI) and reporting quality metrics to senior management.
  • Acting as the primary point of contact with third-party organizations on all quality-related matters and QMS.
  • Ensuring site readiness for audits at any time.
  • Reviewing and approving batch records and quality control records to release products into the market.
  • Conducting annual product quality reviews and implementing recommendations in a timely manner.
  • Reviewing and approving stability, process validation, and analytical method validation protocols and summary reports, and performing batch releases.
  • Developing and driving continuous improvement initiatives.
  • Enhancing quality culture and quality maturity through proactive interactions and engagement with the team.
Requirements

To succeed in this role, you will need:

  • A strong understanding of regulatory requirements and industry standards.
  • Excellent communication and interpersonal skills.
  • Ability to work effectively in a team environment.
  • Strong problem-solving and analytical skills.
  • Proven experience in quality assurance or a related field.


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