Senior Quality Assurance Specialist

il y a 2 semaines


Paris, Île-de-France Groupe ProductLife Temps plein
Job Title: Senior Qa H/F

Groupe ProductLife is seeking a highly motivated and experienced Quality Assurance Specialist to join our team. As a key member of our quality team, you will be responsible for ensuring the quality of our products and processes, while maintaining compliance with regulatory requirements.

Responsibilities:
  • Develop and implement quality control procedures to ensure raw materials, intermediate, and finished products meet specified quality standards.
  • Collaborate with the Quality Control department to address any quality issues or deviations.
  • Ensure that all manufacturing processes adhere to current Good Manufacturing Practices (cGMP) and other relevant regulatory requirements.
  • Manage and maintain comprehensive documentation for all quality assurance activities, including batch records, deviations, CAPA (Corrective and Preventive Actions), and change controls.
  • Conduct regular risk assessments of manufacturing processes 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.

Groupe ProductLife is an equal opportunities employer and welcomes applications from all qualified candidates.


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