- Strong knowledge of data integrity requirements asapplied to a GMP facility (physical & electronic data).
- Good knowledge of the principles of EU Good Manufacturing Practice (GMP).
- Past experience of working with QMS processes applicable to a GxP Pharmaceutical manufacturing environment.
- Past Experience of working in a GMP Quality Control/Production department preferred.
- Past experience of working in Computerised systems validation.
- Past experience of executing/managing risk assessments using FMEA preferred.
- The ability to utilise computer programs such as Visio, Microsoft Excel, Power Point, Outlook, DocuSign. As well as local electronic QMS tools.
Data Integrity Specialist - Woking, United Kingdom - CK Science
Description
Data Integrity Specialist - Quality Systems
CK Group are recruiting for a Data Integrity Specialist - Quality Systems to join a pharmaceutical company at their site based in Pirbright, woking on a 11 month fixed term contract.
The Company:
Our client is a leading manufacturer of vaccines, parasiticides and pharmaceuticals to protect animals. They are also one of the fastest growing animal health companies in the UK.
The Role:
You will ensure that the quality systems under your responsibility will be in adherence with the plans and expectations from the local and corporate quality teams.
You will support the site Data Integrity Governance program, ensuring management of records and data throughout the data life cycle according to risk management principles aswell as support with process mapping, data mapping, risk assessments, mitigation actions and associated documentation.
You will advise on the Data Integrity requirements defined Corporate Quality Assurance, Eudralex/MHRA and other regulatory bodies applicable to bio-pharmaceutical industries.
You will work proactively as part of the site Quality Systems team with all general aspects of GMP and compliance.
Your Background: