Senior CSV Officer
We are seeking a highly motivated and experienced Senior CSV Officer to join our team in the canton of Vaud, Switzerland.
Our client is an independent Swiss biopharmaceutical group dedicated to developing innovative treatments in oncology and infectious diseases. They are committed to innovation and patient health, with expertise in clinical development and the manufacturing of complex drugs.
In this role, you will contribute to the development of innovative treatments by supporting the Computerized Systems Validation Head in maintaining and facilitating compliance for CSV activities. You will work closely on implementing and writing required documentation, applying GAMP5 principles and other relevant standards applicable in an R&D driven organization with GxP and 21 CFR part 11 focus.
Your Missions:
* Drive 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, audits, 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 systems.
* Review, assess, and approve implementation of changes in the area of responsibility (process, validation templates…).
* Ensure awareness of users on CSV and data integrity (authoring training documents, and providing training).
Your Profile:
1. You have a Bachelor's degree in sciences or IT.
* 5-6 years of 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, ...).
Advantages:
* A company at the forefront of its field and with strong values.
* Attractive remuneration, depending on experience.
* Teleworking 2 days/week.