Head of QC Excellence Instrumentation

vor 1 Monat

Bern, Schweiz CSL Vollzeit

We are currently looking for a Head of QC Instrumentation. In the role as Head of QC Instrumentation you will lead a team of instrumentation specialist to support laboratory instrumentation and automation infrastructure in an operational testing environment. With your team you are responsible that QC equipment at our site in Bern, Switzerland is qualified and brought into operation in compliance with GxP requirements. With your peers at our sites in Europe, Australia and the United States you collaborate closely to increase process excellence and ensure regulatory compliance.

Your responsibilities include, but are not limited to:

Oversee and lead a team of instrumentation specialist to support laboratory instrumentation and automation infrastructure in an operational testing environment

Ensure laboratory instrumentation and equipment are qualified, calibrated and maintained in compliance with GxP requirements

Support the validation and lifecycle management of laboratory automation systems and software applications

Maintain working knowledge of regulations and guidelines as related to laboratory instrumentation and computerized systems (i.e. USP, 21CFR Part 11, Annex 11 regulations)

Establish and maintain user support for operational QC labs on instrumentation and equipment

Participation and representation of QC in regulatory inspections as related to instrumentation, automation and equipment qualification and lifecycle activities

Develop and establish lean processes for instrumentation lifecycle activities, collaborating with a team across all manufacturing sites within the CSL Behring network

Who you are:

In this role you will collaborate with relevant stakeholders to ensure laboratory equipment and automation systems are operating in a qualified environment. With your proactive and self-responsible approach you take decisions and drive progress forward.

The below competencies will help you to be successful in this role:

University degree in a relevant scientific discipline (Biology, Microbiology, Chemistry, etc.)

5+ years' experience in a pharmaceutical/medicinal GMP testing environment using a variety of testing instrumentation, experience in equipment qualification and lifecycle activities are highly advantageous

First management and leadership experience in an operational environment

Knowledge of regulations on computerized systems and laboratory automation and willingness to extend skills and know-how on the field

Strong written & verbal communication in German and English, both oral and written to ensure effective collaboration with peers and cross-functional teams both locally and globally across all CSL Behring sites

Strong analytical/problem solving and organizational skills

Able to work independently and as a team member in a high performance environment

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you.

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