Quality Assurance Specialist

13 hours ago

Mumbai, Maharashtra, India beBeeQuality Full time ₹ 15,00,000 - ₹ 25,00,000

Our organization is seeking a skilled Quality Assurance Manager to join our team. This role involves overseeing the quality of pharmaceutical products manufactured by contract manufacturing organizations (CMOs).

The successful candidate will have a strong background in quality assurance, with experience in managing CMOs and ensuring compliance with regulatory requirements.

Key Responsibilities:
  • Ensure that all operational aspects of manufacturing comply with Sanofi's quality directives and relevant cGMP regulations.
  • Maintain valid QA agreements with CMOs, performing periodic reviews and negotiations as needed.
  • Conduct quality audits of CMOs and suppliers, identifying areas for improvement and implementing corrective actions.
  • Monitor product technical complaints and investigate root causes, working with CMOs to implement corrective actions.
  • Manage all quality issues, deviations, and complaints according to Sanofi's quality management system.
  • Assess quality trends and drive continuous improvement initiatives to enhance process and product quality performance.
Requirements:
  • Bachelor's degree in a relevant field, such as pharmacy or life sciences.
  • Minimum 5 years of experience in quality assurance, preferably in a pharmaceutical industry.
  • Strong knowledge of cGMP regulations and quality management systems.
  • Excellent communication and interpersonal skills.
  • Ability to work effectively in a team environment.
Benefits:

Our organization offers a competitive salary and benefits package, including medical, dental, and vision insurance, retirement savings plan, and paid time off.

Others:

We are an equal opportunity employer and welcome applications from diverse candidates. Please submit your resume and cover letter to [insert contact information].

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