Digital QA Manager, GCP
Jim Gleeson is recruiting for a Digital QA Manager, GCP to join an innovative and highly successful biotechnology developing novel treatments for neurological disorders.
As Digital QA Manager, GCP you will ensure that all computerised systems are implemented and maintained in accordance with relevant legislation and company procedures as they migrate from paper based systems to a fully digital solution.
Key Duties will include:
- Promotion of a GxP compliant environment for all clinical trial activities.
- Contribution to the development of departmental processes and procedures as well as reviewing and giving input on cross-functional procedures involving an element of information technology.
- Report CSV audit trends and recommendations to the Senior Manager Digital QA.
- Verification that data integrity principles are adhered to within R&D activities.
- Preparation for and supporting sponsor inspections and external audits conducted by regulatory authorities and other external bodies.
As Digital QA Manager, GCP you will require the following:
- Extensive experience of supporting the implementation and validation of computerised systems within a regulated framework.
- A detailed know of CSV and GCP, knowledge of GVP and GMP would be advantageous.
- A thorough understanding of risk-based system validation.
- A solid understanding of the FDA, EMA and MHRA regulatory guidelines for IT systems.
- In depth knowledge of 21 CFR Part 11 compliance.
- Excellent interpersonal and communication skills.
For more information or to apply for this position, please contact Jim Gleeson on 01438 842973 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46739 in all correspondence.