For our client, a biopharmaceutical company localized in Switzerland in the Canton of Neuchâtel, we are looking for a:
Senior QC Microbiology Manager
1 year contract - 100%
- Recruits, interviews, and hires QC personnel.
- Establishes laboratory team objectives, sets testing priorities, and coordinates laboratory resources to align with objectives.
- Conducts performance reviews, employee development plans with direct reports. Provides developmental opportunities for laboratory personnel through training and project assignments.
- Responsible for assuring laboratory personnel are qualified through proper training on appropriate operating procedures, training modules, GMP requirements and regulatory standards.
- Responsible for assuring all equipment used for environmental monitoring and testing is in working order and in a qualified state.
- Reviews approves and authorizes QC generated test results.
- Trends Environmental Monitoring and generate periodic reports, presents results in site committees and handles trends and out of limit results appropriately and in a timely manner.
- Ensures deviations, CAPAs and Change controls are handled appropriately and in a timely manner.
- Authors, reviews and approves complex GMP documentation such as laboratory procedures, work practices, plans, risk assessments, protocols and reports.
- Reviews, evaluates, and prioritizes projects to improve compliance status and operational efficiency of the laboratory. Designs, implements, and sustains LeanLab initiatives such as 5S, deviation reduction, right first time, visual management.
- Performs other tasks as assigned
- Bachelor's degree in Microbiology, Biology, Biochemistry or related Life Science
- At least 8 years of experience in a GMP-regulated environment and at least 3 years of experience managing Microbiology Laboratory Operations.
- Must be proficient with the Quality systems and business processes associated with Microbiology testing (product and Environmental Monitoring) as well as facility / utility operations in a Pharmaceutical environment
- Experienced with regulatory inspections and audits, able to present and defend complex topics as Subject Matter Expert (e.g. QC processes and procedures, rationales and justifications, risk assessments, deviations).
- Proven experience leading teams and managing direct reports.
- Experienced leading teams through change.
- Team-player, able to work collaboratively and cross-functionally in project teams.
- Effective verbal communication skills, able to interact at all levels of the organization: managers, peers, lab analysts, suppliers and customers.
- Excellent technical writing and presentation skills.
- Analytical and structured approach to problem solving. Proficient with problem solving and investigation tools.
- Good knowledge of Data Integrity principles
- Good knowledge of Lean principles, 5S and visual management.
- Fluent in English and professional command of French (written and verbal)
YOUR KELLY CONTACT
Mrs Charline Maire
Consultant Professional Staffing Life Science
Kelly Scientific Geneva