Job Reference: J5633353
Updated On: 16/06/2020
Status: Open to Applications
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Role OverviewWe are currently looking for a Quality Associate - GLP to join a leading biopharmaceutical company based in the Berkshire area. As the Quality Associate - GLP you will be responsible for supporting Global Quality Lead auditors by assisting with all Good Laboratory Practice (GLP) auditing activities.
Key Duties and ResponsibilitiesYour duties as the Quality Associate - GLP will be varied however the key duties and responsibilities are as follows:
1. As the Quality Associate, you will be responsible for performing routine audits and assisting with the update of the research quality processes/procedures, with the potential to take on additional team-related activities.
2. In your role as the Quality Associate, you will review Study Plans, Study/Phase Reports and Standard Operating Procedures (SOPs), for audit by the team – utilising Veeva, TrackWise, Excel
3. You will be responsible for tracking CAPAs and following up with internal CAPA owners using TrackWise.
4. As the Quality Associate, you will prepare and review GLP, GRP and GCP Lab Refresher training content.
Role RequirementsTo be successful in your application to this exciting opportunity as the Quality Associate - GLP we are looking to identify the following on your profile and past history:
1. Relevant degree in a related subject.
2. Proven industry experience using databases and web-based software (e.g. TrackWise, Veeva Vault).
3. A working knowledge and practical experience with GLP auditing a working competency in the OECD GLP Regulations.
Key Words: GLP / QUALITY / AUDIT / TRACKWISE / GLP / GRP / MS VISIO / VEEVA / STUDY PLANS / VEEVA VAULT
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