QC Equipment Qualification Specialist

il y a 3 jours


Toulouse, Occitanie, France Optimus Life Sciences Temps plein

Job Summary:

We are seeking an experienced QC Equipment Qualification Specialist to join our team at Optimus Life Sciences. As a key member of our quality assurance department, you will be responsible for ensuring the compliance of analytical equipment in our Phys. Chem. and Bioanalytics QC laboratories.

Key Responsibilities:

  • Conduct thorough qualification and validation procedures for analytical equipment, adhering to cGxP standards and regulatory guidelines.
  • Develop and maintain essential qualification documentation, including URS, Risk Assessment, and OQ/PQ Plans and Reports.
  • Oversee testing phases (IQ, OQ, PQ) and ensure seamless compliance with quality management systems.
  • Evaluate and authorize qualification/validation reports, providing expert recommendations as necessary.
  • Maintain equipment within Phys. Chem. and Bioanalytics QC laboratories, adhering to relevant SOPs and directives.
  • Foster collaboration with cross-functional teams and stakeholders, promoting a culture of quality and excellence.
  • Serve as a subject matter expert on laboratory system qualification during audits and inspections, ensuring regulatory compliance.
  • Assume the role of administrator for dedicated lab systems, following defined SOPs and directives.

Requirements:

  • Possession of a degree in fields like Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Engineering, or equivalent experience as an Analytical Lab Technician.
  • Extensive background in qualifying analytical equipment, with a strong understanding of pertinent regulatory guidelines.
  • Proficient comprehension of quality management systems, such as TrackWise.
  • Strong communication abilities, with excellent interpersonal skills and adaptability in a dynamic work environment.
  • Proficiency in English and French, with the ability to communicate effectively with cross-functional teams and stakeholders.

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