|Job title :||CSV Senior Officer - (12 months) Remote|
|Job type :||Contract/Freelance|
|Contact name :||Brook Bridges|
|Contact number :||+49 (0) 69 2222 2888|
|Contact email :||email@example.com|
As part of their ongoing growth, an independent biopharmaceutical company are searching for a Senior CSV Officer to join their dynamic Quality team based in Switzerland on a 12-month basis.
This job is your opportunity to be at ground level as this company launch the next stage of their development. Being at the forefront of innovative treatments in Oncology and Anti-infectives, you'll contribute by supporting the CSV Lead in endorsing and maintaining the appropriate compliance level for computerized systems validation.
You'll play a key role, assisting with the implementation and writing of required documentation, applying your strong knowledge of GAMP5 principles and other relevant standards applicable.
What's in it for you?
· Fully remote working (On-site will be required for on-boarding)
· The opportunity to join a successfully company at the forefront of advanced scientific developments
· The chance to work across the many areas within clinical development and the pharmaceutical industry.
· Rewarding work in a friendly and supportive work environment.
Your main responsibilities:
· Carrying out and overseeing equipment qualification and CSV activities.
· Producing and managing validation master plans, protocols and reports.
· Create key CSV deliverables and/or assist business units in writing CSV documentation
· Participating in the management of the eQMS.
· Offering internal training in the area of validation for user specific systems.
· Participating in strategic oversight and reporting of quality assurance activities.
What you bring:
· At least a bachelor's in sciences or in IT with 5-6 years working experience as CSV in the pharmaceutical industry
· Experience working in a GCP environment
· Working knowledge of related regulatory requirements in the life sciences industry (GAMP 5, 21 CFR part 11, ...)
· Excellent writing skills for scientifically sound technical documents, instructions, validation protocols and reports in English, French is an asset
For more information on this position reach out to firstname.lastname@example.org , or apply now for immediate consideration.