Business analyst Offres d'emploi - Corsier-sur-Vevey, VD
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Business analyst • corsier sur vevey vd
Dernière mise à jour : il y a 2 jours
International Life Sciences - Solutions de recrutement.Permanent position – canton of Vaud.Swiss biopharmaceutical group dedicated to developing innovative treatments in oncology and infectious dis...Voir plusDernière mise à jour : il y a plus de 30 jours
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Senior CSV Officer
RecrutisEpalinges, Vaud, CHIl y a plus de 30 jours
Type de contrat
- Quick Apply
Description de posteYou have a Bachelor in sciences or in IT 5-6 years working experience as CSV in the pharmaceutical industry, including at least 2 recent years in a clinical environment (GCP) Auditing experience in the pharmaceutical industry Proven Data Integrity experience Excellent writing skills for scientifically sound technical documents, instructions, validation protocols and reports in English Working knowledge of related regulatory requirements in the life sciences industry (GAMP 5, 21 CFR part 11, ...) tasks effectively. nts, ensuring timely completion. A company at the forefront of its field and with strong values! Attractive remuneration, depending on experience Teleworking 2 days / week.
International Life Sciences - Solutions de recrutement
SENIOR CSV OFFICER – M / W
Permanent position – canton of Vaud , Switzerland
Our Client is an independent Swiss biopharmaceutical group dedicated to developing innovative treatments in oncology and infectious diseases. Committed to innovation and patient health, our client stands out for its expertise in clinical development and the manufacturing of complex drugs.
In this great opportunity, you will contribute to the development of innovative treatments supporting the Computerized Systems Validation Head in endorsing, maintaining and facilitating the appropriate compliance level for CSV activities. You work closely on the implementation and writing of the required documentation. You apply the GAMP5 principles and other relevant standards applicable in an R&D driven organization with GxP and 21 CFR part 11 focus and you closely collaborate with the CSV Lead, Business Process Owner and System Owner to create the synergy between business, Quality and IT.
Your missions
- Drive the compliance excellence with GxP standards and internal quality guidelines
- Lead inspection readiness efforts alongside the validation team to ensure we’re always audit ready. Represent Quality during inspections, audit or other enquiries on CSV matters (e.g. due diligence)
- Oversee and evaluate CSV-related vendor documentation, ensuring vendor compliance.
- Create / approve CSV deliverables and / or assist business units in writing CSV documentation (e.g., Validation Plan, FRS, Test Scripts, Validation Report), and ensure proper filing in respective document management system.
- Review, assess and approve implementation of changes in the area of responsibility (process, validation templates…)
- Ensures awareness of users on CSV and data integrity (authoring training documents, and providing training)
Your profile
Advantages
Are you motivated to take on new challenges? Don’t hesitate any longer and APPLY!