Senior Quality Control Professional

il y a 1 semaine


Paris, Île-de-France Groupe ProductLife Temps plein
Job Title: Quality Assurance Specialist

Groupe ProductLife is seeking a highly motivated Quality Assurance Specialist to oversee the quality control process, manage compliance, and conduct risk assessments within the manufacturing environment.

Key Responsibilities:

  • Ensure quality control procedures are in place to meet specified quality standards.
  • Collaborate with the Quality Control department to address quality issues or deviations.
  • Ensure manufacturing processes adhere to cGMP and other regulatory requirements.
  • Maintain up-to-date knowledge of regulatory changes.
  • Manage and maintain comprehensive documentation for quality assurance activities.
  • Review and approve SOPs related to quality assurance and manufacturing processes.
  • Conduct regular risk assessments to identify potential quality issues.
  • Implement corrective actions to mitigate identified risks and ensure product integrity.
  • Provide training and guidance to production and quality control staff on quality standards, regulatory requirements, and company procedures.
  • Coordinate and participate in internal and external audits and inspections.

Requirements:

  • Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or a related field.
  • 10+ years of experience in Quality Assurance within the pharmaceutical industry.
  • In-depth knowledge of cGMP, FDA/EMA regulations, and quality management systems.
  • Experience with regulatory audits and inspections.
  • Familiarity with electronic Quality Management Systems (eQMS).
  • Strong attention to detail and excellent problem-solving skills.
  • Effective communication skills, with the ability to train and influence others.
  • Certification in Quality Management (e.g., Six Sigma, ISO 9001) is a plus.


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