CSV Quality Manager
Northwich (hybrid)
Competitive Salary plus bonus and car allowance
My client are a leading specialist in veterinary pharmaceuticals, are committed to developing, manufacturing, and marketing high-quality products for veterinarians worldwide. They are seeking an experienced Quality Technology Manager with CSV and leadership experience to join their dynamic team.
About the Role:
As a Quality Technology Manager, you will play a pivotal role in ensuring the compliance and efficiency of their GxP computerised systems. You will be responsible for defining and managing the GxP Computerised System Life-Cycle for all GxP software and computerised technology within the division. Your expertise in computer system validation, data integrity, and regulatory compliance will be essential in driving quality initiatives.
Key Responsibilities:
- Overseeing the validation of business-level GxP SaaS systems.
- Collaborating with project teams to mitigate validation risks.
- Acting as the owner of the GxP Computerised System Life-Cycle.
- Providing expert advice on technology QMS, data integrity, and CSV.
- Developing and delivering training programs on data integrity and computerised systems.
- Supporting internal and external audits.
- Managing a team responsible for CSV activities.
Ideal Candidate:
To apply you should demonstrate:
A degree in a relevant scientific discipline or equivalent experience.
- Several years of experience in the pharma/biotech industry with a focus on CSV.
- Proven leadership skills.
- In-depth knowledge of regulatory guidelines (FDA, EMA, GAMP, ICH).
- Experience in regulatory inspections and auditing.
- Ability to manage multiple projects and priorities.