Quality Governance Specialist

2 weeks ago

Bengaluru, Karnataka, India beBeeGovernance Full time ₹ 15,00,000 - ₹ 28,00,000
Job Title: Quality Governance Specialist

We are seeking a highly skilled and experienced Quality Governance Specialist to join our team. This role will be responsible for providing quality oversight and governance to ensure compliance with relevant regulations and industry standards.

  • Key Responsibilities:
  • Supporting and participating in regulatory agency inspections and third-party audits at contract manufacturing organizations.
  • Establishing quality performance indicators (QPIs) and reporting quality metrics to senior management.
  • Acting as the primary point of contact with third-party organizations on all quality-related matters and quality management systems.
  • Ensuring site readiness for anytime audits.
  • Reviewing and approving batch records and quality control records to release products into markets.
  • Annual product quality reviews and ensuring recommendations are implemented in a timely manner.
  • Reviews and approves stability, process validation, and analytical method validation protocols and summary reports, performing batch releases.
  • Developing and driving continuous improvement initiatives.
  • Enhancing quality culture and quality maturity through proactive interactions and engagement with teams.
  • Developing relationships and negotiating quality issues with CMO quality leadership teams for enhanced compliance.

Requirements:

  • Bachelor's degree in a related field or equivalent experience.
  • M.Sc degree preferred.
  • A minimum of years of experience in quality assurance or a related field.
  • Proven track record of ensuring compliance with regulatory requirements and industry standards.
  • Strong leadership and communication skills.
  • Ability to work independently and as part of a team.

About Us:

We are a leading contract manufacturing organization dedicated to delivering high-quality products to our customers. We are committed to maintaining the highest standards of quality and customer satisfaction.

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