Work Schedule

Standard (Mon-Fri)

Environmental Conditions

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

Job Description

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.
• With regards to the controlled substances (as per ref. to Betaubungsmittelgesetz, BetmG 812.121) act as responsible person and approve Purchase Order Requests and authorize the consumption for testing purposes limited to the actual required quantities.

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.