Qualification Manager

Hobson Prior are currently seeking a Qualification Manager to join a brilliant biotech organisation on a permanent basis located in Bern with the ability work from home one day a week. Our client is focused on protecting and enhancing people's lives.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this role, you will be responsible for handling the implementation and reporting of functional tests, procedures, and certifications for new systems.
• Contribute to regulatory examination and response actions.
• Guarantee continuous reporting quality in assistance of CAPEX and OPEX projects.
• Accountable for preliminary qualifications of gear and facilities such as cleanroom facilities, bioprocess equipment, clean utilities.
• To mitigate future recurrence, you will accomplish examinations of process system aberrations and execute counteractive and precautionary activities as needed.
• Warrant the qualification status of the production site in Bern.
• The ideal candidate will guide and evolve staff employees in the C&Q function.

Key Skills:

• Constant communication with staff, managers, within the EBSI association, and with external authorities and associates.
• Thinks analytically to resolve issues.
• Communication skills both written and verbally.
• Past involvement in a leadership role.

Requirements:

• Educated to a degree level in an engineer, chemistry, biology, pharmacy or similar discipline.
• Familiarity in a pharmaceutical setting.
• Know-how in plant and room trainings in the GMP setting.
• Acquaintance with quality assurance (GMP) and the essential qualification and validation dealings such as RA, URS, DQ, IQ, OQ, PQ.
• GEP experience (Good Engineering Practice).
• Ability to conduct examinations in a pharmaceutical area.
• Fluency in the English and German language.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.