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QC CSV Engineer
vor 2 Wochen
In 12 years, the Efor Group
has reached the leading position in Life Sciences consulting
. Our ambition is to build a global leading position in our market by 2028.
In Switzerland, we work with 300 experts who support our customers on their various projects in the French- and German-speaking parts. We help our customers diversify and grow through the work of our consultants and the technical expertise of our Technical Department.
CVO-EUROPE SA (part of the Efor Group)
, based
Avenue de l'Etang 61 – 1219 Châtelaine
, is recruiting and manage client relationships. The recruitment is for assignments and projects carried out for our clients, as well as for company mandates
RESPONSIBILITIES
You will be responsible for the Analytical Instrument Qualification, including Computerized System Validation in the QC laboratories.
Your main responsibilities will be:
- Comply with cGMPs and Data Integrity requirements through applicable guidelines and procedures,
- Represent the QC department on project core teams and participate in strategy discussions,
- Write and/or review validation plans, protocols and reports,
- Oversee validation activities executed by QC analysts, provide training and support,
- Maintain validation status of analytical instrument, including computerized systems,
- Provide technical assessments on change controls, deviations, and investigations,
- Support and prepare inspections, audit responses and regulatory submissions.
QUALIFICATION/SKILLS
- You have a bachelor's/master's degree (EPF, HES, university, bac+5) in engineering, information systems or equivalent.
- You have a first experience in validation life cycle requirements for cGMPs laboratory systems and are familiar with the regulatory requirements and guidelines in force in the pharmaceutical sector (GLP, GMP, ICH, 21 CFR part 11, etc.).
- You have participated in audits/inspections with the FDA, other notified bodies, or Health Authority.
- You speak fluently French and English.
