Regional Quality Assurance Specialist
Jocelyn Blackham at CK Science is currently recruiting for a Regional Quality Assurance Specialist to join a global pharmaceutical company based in Berkshire. This role is offered on a full time temporary basis for 6 months initially.
Your main responsibilities in this role will be to:
- Lead the remediation of GxP risks identified by internal audit observations for QA Global Business Processes running across the SAP based MRP Systems.
- Assess in detail all GxP relevant SAP data processes for security and audit trail compliance
- Work with relevant business process and technical SAP SME's to locate and/or generate the appropriate validation documentation
- Locate evidence of testing or where missing to create a body of documentation that fulfils the requirement to demonstrate the system is appropriately validated and fit for purpose
You are required to have the following qualifications, skills and experience:
- Scientific/Technical/Quality degree or equivalent
- Strong pharmaceutical SAP background
- Knowledgeable with ERP/SAP systems and QA business process development
- Strong understanding GxP business process flows in detail
- In depth knowledge of 21 CFR Part 11 and Eudralex Volume 4 Annex 11 requirements around audit trail and security
- Experienced working with business and IT SMEs across business process streams to assess GxP risk and implement solutions
- Change Management experience
- Knowledge of Supply Chain best practices
If you are employed by this client you will be joining a global pharmaceutical company company based in Berkshire.
For more information or to apply for this Regional Quality Assurance Specialist position please contact Jocelyn on +44 (0)1438 723 500 or email email@example.com. Alternatively, please click on the link below to apply online now.
CK Science is an Equal Opportunities employer who 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 ST33592 in all correspondence.