International Life Sciences Solutions
SENIOR CSV OFFICER - M/W
Permanent Position in the 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 exciting opportunity, you will contribute to the development of innovative treatments by supporting the Computerized Systems Validation Head in endorsing, maintaining and facilitating appropriate compliance levels for CSV activities. You will work closely on implementing and writing required documentation while applying GAMP5 principles and other relevant standards applicable in an R&D driven organization with GxP and 21 CFR part 11 focus. You will collaborate closely with the CSV Lead, Business Process Owner and System Owner to create synergy between business, Quality and IT.
Your Key Responsibilities:
* Drive Compliance Excellence with GxP Standards and Internal Quality Guidelines
* Lead Inspection Readiness Efforts alongside the Validation Team to Ensure Audit-Readiness. 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 System
* Review, Assess and Approve Implementation of Changes in the Area of Responsibility (Process, Validation Templates…)
* Educate Users on CSV and Data Integrity (Authoring Training Documents, Providing Training)
Your Profile:
1. Bachelor's Degree in Sciences or IT
* 5-6 Years' 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, ...)
What We Offer:
* A Company at the Forefront of Its Field with Strong Values
* Attractive Remuneration Depending on Experience
* Teleworking 2 Days a Week
Are You Motivated to Take on New Challenges? Don't Hesitate Any Longer