Senior Quality Assurance Specialist

il y a 2 semaines


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

PLG is currently seeking a highly motivated individual to join our team as a Senior QA Specialist. This role will be responsible for overseeing the quality control process, managing compliance, conducting risk assessments, and supporting continuous improvement initiatives within the manufacturing environment.

Responsibilities:
  • Quality Control: Monitor and oversee 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.
  • Regulatory Compliance: Ensure that all manufacturing processes adhere to current Good Manufacturing Practices (cGMP) and other relevant regulatory requirements.
  • Maintain up-to-date knowledge of regulatory changes and ensure the organization's practices are aligned with these changes.
  • Documentation Management: Manage and maintain comprehensive documentation for all quality assurance activities, including batch records, deviations, CAPA (Corrective and Preventive Actions), and change controls.
  • Review and approve Standard Operating Procedures related to quality assurance and manufacturing processes.
  • Conduct regular risk assessments of manufacturing processes to identify potential quality issues.
  • Implement corrective actions to mitigate identified risks and ensure product integrity.
  • Training and Development: Provide training and guidance to production and quality control staff on quality standards, regulatory requirements, and company procedures.
  • Audit and Inspection: Coordinate and participate in internal and external audits and inspections.
Requirements:
  • Education: Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or a related field.
  • Experience: 10+ years of experience in Quality Assurance within the pharmaceutical industry.
  • Skills: 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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