Csv Manager

**Title: CSV Manager**

**Location: Amersham (Hybrid Working Available)**

**Contract Length: 6 Months (Opportunity for extension)**

**Rate: £60 p/h Umbrella (Negotiable)**

My client is looking for someone with Quality Assurance/ Quality Engineering experience within CSV (Computer Systems Validation) to support working on key global projects.

**Responsibilities**:

- Provide CSV support in key global projects concerning computerised system, ensuring compliance with the QMS and regulations.
- Review and approve GxP assessment as well as Validation Master Plans, and where necessary the entire Validation Life Cycle documentation. Supports projects and ongoing maintenance of the systems
- Working closely with the Biopharma QARA CSV IT and IT Compliance Manager supports the roll out of the CSV training and education
- Provides input, reviews and approves of quality records related to CSV including Deviation, Change Controls and CAPAs.
- Supports the Biopharma CSV team in implementation of the risk-based approach to CSV system, in line with the regulation and ensuring QMS compliance

**Criteria**:

- Bachelor's Degree and minimum of 7 years working in regulated medical devices, pharmaceutical or life sciences industry in Quality or related functional roles specific to Computerised System Validation
- Quality Assurance/ Quality Engineering experience in CSV in a GMP environment is essential, proficiency on GAMP 5 and FDA and EU regulations
- Understanding Medical Devices QMS and regulatory requirements including but not limited to FDA CFR 21 820, ISO 13485 and ISO 9001 will be advantage
- Exceptional analytical, problem solving & root-cause analysis skills
- Excellent organisational, presentation, meeting facilitation and report writing skills