QC Equipment Qualification Specialist
il y a 2 semaines
QC Equipment Qualification Engineer – Toulouse, France
Optimus Life Sciences is seeking an experienced QC Equipment Qualification Engineer to join our dynamic team in Toulouse, France. As a key member of our quality assurance team, you will be responsible for conducting qualification and validation procedures for analytical equipment in our Phys. Chem. and Bioanalytics QC laboratories.
Your Responsibilities:
- Conduct qualification and validation procedures for analytical equipment in Phys. Chem. and Bioanalytics QC laboratories.
- Draft essential qualification documentation such as URS, Risk Assessment, and OQ/PQ Plans and Reports.
- Oversee testing phases (IQ, OQ, PQ) and ensure compliance.
- Evaluate and authorize qualification and validation reports as necessary, adhering to cGxP standards.
- Maintain equipment within Phys. Chem. and Bioanalytics QC laboratories according to relevant SOPs.
- Foster collaboration with cross-functional teams and stakeholders.
- Serve as a subject matter expert on laboratory system qualification during audits and inspections.
- Assume the role of administrator for dedicated lab systems following defined SOPs and directives.
Your 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.
- Proficient comprehension of pertinent regulatory guidelines.
- Familiarity with quality management systems such as TrackWise is advantageous.
- Strong communication abilities.
- Adaptability to thrive in a dynamic work environment.
- Effective interpersonal skills.
- Proficiency in English and French.
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