QUALITY ASSURANCE ENGINEER – GxP (M/F)

QUALITY ASSURANCE ENGINEER – GxP (M/F)

Lieu Grand Est
Type d'expertise Life Science
Type of Contract CDI

As a Quality Assurance Engineer, you will be part of a dedicated team responsible for quality assurance activities spanning various departments including Laboratory, Production, Projects, and Supply Chain.

 

  • Documentation Management: Creating, updating, and managing quality documentation, including specifications, procedures, protocols, and test reports.
  • Internal and External Audits: Planning, coordinating, and conducting internal quality compliance audits, as well as managing external audits from regulatory bodies and clients.
  • Process Validation: Participating in the validation of manufacturing, testing, and quality control processes in accordance with GMP (Good Manufacturing Practice) standards.
  • Deviation and CAPA Management: Identifying, investigating, and managing quality system deviations, developing corrective and preventive action plans.
  • Training: Developing training modules on quality procedures and GMP for employees to ensure compliance.
  • Audit Support: Preparing required documentation and providing support during regulatory inspections and audits.
  • Non-Conformity Management: Handling non-conformities in collaboration with Production, Quality Control, and Development departments, implementing corrective measures.
  • Regulatory Compliance Monitoring: Monitoring regulatory developments in pharmaceutical quality and ensuring company compliance with these regulations.

With a degree in Engineering, Pharmacy, or equivalent at the master’s level in Pharmaceutical Sciences, Chemistry, or a related field, you should have initial experience in quality assurance.

You possess a deep understanding of GMP regulations and current pharmaceutical legislation. You enjoy working in a team and collaborating with various departments.

 

 

Error: Contact form not found.