QC Equipment Qualification Specialist
il y a 3 jours
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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