Manager Bio-/chemical Quality Control

vor 3 Wochen

Lengnau, Schweiz Thermo Fisher Scientific Vollzeit

**Work Schedule**

Standard (Mon-Fri)

**Environmental Conditions**

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

The Quality Control management team is seeking a leader for the Bio-/Chemical Unit (BCQC) at Thermo Fisher, Lengnau site.

The job holder is responsible for maintaining a brand-new laboratory for Biochemical and Chemical testing and Monitoring Utilities. This includes Clean Utilities, Cleaning Validation programs, In-process controls, and Product release testing.

**A day in the Life**:

- Lead, develop, and maintain brand-new laboratories for Biochemical and Chemical analytics (BCQC) and ensure procedural documents are in place to accurately lead related processes and testing.
- Ensure BCQC labs are every time ready for Health Authorities inspection (audit readiness) & Customer visits.
- Responsible for the timely validation, and re-validation of BCQC test procedures as well as evaluation, procurement, qualification, re-qualification, maintenance (service/cleaning), calibration, and monitoring of equipment.
- Collect QC analytical samples and materials and reagents promptly and in accordance with regulations, including "reference and control" materials.
- Timely execution and evaluation of analytical testing (either internally or externally tested) to ensure business expectations are met.
- Ensure testing results are detailed according to GDP and in a way to preserve data integrity.
- Consistent and timely investigation of OOE/OOS-results and laboratories deviations.
- On demand, support and lead internal projects.

**Keys to Success**:
Education
- University Degree (Master or higher) in Chemistry, Pharmaceutical or Life Sciences (such as Chemistry, Biochemistry, Biology, etc.) or equivalent experience in the field.

**Experience**:

- At least 5 years' experience in highly regulated industry (GxP, Food, Medical Device).
- Proven experience as people manager in quality control.
- Confirmed experience and knowledge in Biochemical and Chemical methods, method validation, and analytical issue management.
- Proven experience and knowledge in analytical QC methods, method development, validation, and analytical issue management.
- Able to lead direct reports by example, providing technical and personal support.
- Excellent time management skills, with the flexibility to manage changing priorities and multiple tasks at the same time.
- Working proficiency in English is required; ability to communicate in German is a requirement.

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