Senior Quality Assurance Manager

9 hours ago


Ahmedabad, Gujarat, India Biotech Healthcare Full time
About the Role

We are seeking an experienced Senior Quality Assurance Manager to join our team at Biotech Healthcare. This is a fantastic opportunity for a skilled professional to lead quality management initiatives and drive operational excellence.

Key Responsibilities:
  • Develop and implement a robust Quality Management System (QMS) framework, ensuring compliance with regulatory requirements and industry standards.
  • Authorise and review SOPs, master documents, and quality protocols to ensure comprehensive compliance across all operational processes.
  • Oversee the approval process for Site Master Files, Validation Master Plans, Quality Manuals, and stability summary reports.
  • Ensure procedural compliance in handling Change Control Notices (CCN), deviations, market complaints, Out-of-Specification (OOS) issues, CAPA, and IPQA non-conformances.
  • Conduct document reviews for new product launches, ensuring alignment with regulatory requirements.
  • Lead internal audits and self-inspections to assess compliance with quality standards and identify areas for improvement.
  • Investigate quality-related issues, conduct root cause analysis, and implement corrective and preventive actions (CAPA).
Requirements:
  • A strong understanding of regulatory requirements, including FDA, ISO 13485, GMP, and GDP.
  • Proven expertise in developing and implementing QMS processes, handling compliance, and conducting internal audits.
  • Demonstrated ability to lead quality-based projects and manage cross-functional teams.
  • Excellent communication and leadership skills, with a track record of successful project management and stakeholder engagement.
  • A degree in a relevant field, such as Quality Assurance or a related discipline.
What We Offer:
  • A competitive salary of $120,000 per annum, commensurate with experience.
  • A comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.
  • The opportunity to work with a dynamic team and contribute to the success of Biotech Healthcare.
  • A collaborative and supportive work environment, with opportunities for professional growth and development.


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