CSV Expert - Permanent - Up to £65k
Essentially this role will shape the CSV Systems & processess for a developing CDMO in a phase of restructuring.
This will form part of an exciting new validation team whilst the company develops and expands
We need an expert in CSV from the pharmaceutical industry wo can act as the SME for the entire site. This role includes exposure to to the activities & stategy of the senior leadership team.
This would hypothetically appeal to someone very technical in CSV who wants the exposure to projects, strategy & to enhance their skill set beyond technical.
As the subject matter expert for CSV you will shape & develop the validation process for all computerised systems, general responsibilities include;
- Ensure the validation status of computerised systems are compliant with cGMPs
- Responsible for the implementation of a risk-based approach to the validation of Computerised systems in accordance with EU GMP Annex 11, 15 and GAMP 5, whilst ensuring compliance with the company QMS
- Manage validation documentation, commissioning test scripts, validation protocols, summary reports and risk assessments
- Author and report validation documentation to meet regulatory and company requirements including Validation Plans, User Requirement Specifications, Design Specifications and SOPs
- Author, review and execute Qualification Documents (DQ, IQ, OQ, PQ)
- Maintain accurate validation documentation through the validation lifecycle
As the site subject matter expert for CSV your background will ideally be;
- BSc or MSc degree in life science / engineering / computer science
- Proven industry experience in Computer systems within the pharmaceutical industry
- Good knowledge of GAMP5 guide and MHRA GxP Data Integrity Guidance and Definitions, FDA 21 CFR Part 11, EMA Annex 11 regulations
- Broad knowledge of the commissioning and qualification of computerised systems within a GMP regulated environment
- Strong documentation bias. Experience managing and documenting validation processes
Please contact Simon Fowler at Science Solutions to discuss