Data Integrity and Validation Lead
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Are you experienced with Data Integrity and Validation processes within a GMP environment? I have a very exciting role for a global leading company based in Petersfield. Keep reading for more information...
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The primary role of this position is to ensure that validation and data integrity activities are compliant with applicable validation and data Integrity (DI) cGMP regulations across the site. It is integral that this role provides key support to the Site Leadership Team for all validation and DI requirements and assists the site in key compliance activities and responsibilities.
You'll also be a source of expertise for the site in understanding validation, DI and cGMP, implementing them in a practical way, maintaining and improving compliance and be the validation and DI SME for site audits by Regulatory Agencies. Also providing support the design of the corporate DI and validation system as well as oversight across all GxP computerized systems and to work closely the Global Data Integrity Technical Program lead to align on DI strategy for the plant DI execution activities.
Monday to Friday flexible Hybrid working, upto £64,000pa plus bonus and equity shares.
What do you need?
- Experienced in Supply Chain processes and working across multiple business functions at site level to rollout DI and validation requirements. Aiming to ensure excellence in execution with the technical community of the Supply Chain.
- Strong ability to provide visibility and management of priorities and risks and opportunities for DI and validation related activities and elevated to leadership where appropriate.
- Strong background working with corporate functions - such as Global R&D and Global QA - to ensure robust SOPs and Work Instructions are in place to ensure compliant GxP systems.
- Experienced in writing SOPs and Work Instructions and other Quality System Documents.
- Knowledge of GxP (Good Clinical/Manufacturing/Documentation practices)
- Knowledge of FDA Validation and CFR 21 Part 11
- Knowledge of Various software applications and SAP ERP a plus
- Knowledge in Data Infrastructure/Security background is plus as well as any data Integrity & integration experience.
If you feel you have the right expereince and drive to take on the new vacancy then please APPLY or call Steph for more information. Our client are seeking to review CV's IMMEDIATELY!
FPR Group is acting within the capacity of a Recruitment Agency for their client.
Note: this is the location of the town or city the job is in and not the exact location of the employer.