Data Integrity Project Manager - Contract 12-18 months FTC
Data Integrity Project Manager
Healthcare / Pharmaceuticals
12-18 month Contract
South West London
Our client is a well-established healthcare business with a long history providing well-known brand name products. An opportunity as a Data Integrity Manager has arisen to project manage the implementation of Data Integrity. Working to strict standards such as EU Annex 11 (GMP_ and CFR Part 11 for IT Systems.
A successful candidate will be expected to lead, develop and execute the implementation plan, working with relevant parties across the business. Developing SOP’s to provide a framework for Data Integrity, working closely with the Quality, Technical and IT Leadership teams to ensure procedures are achievable and sustainable.
- Develops the DI implementation plan in line with GMP and the company DI Policy in compliance with EU Annex 11 (GMP) and CFR Part 11 for IT systems.
- Works closely with Heads of Quality, IT, Technical, Operations and the QC Lab Manager to prioritise activities required, and agree support required and completion dates.
- Identifies and prioritises changes required to infrastructure and equipment. Helps to develop specifications and validate the new solutions.
- Arrange and co-ordinate training for staff during implementation of new DI procedures and activities.
- Where 3rd party support is required, co-ordinates work with Integrity Solutions.
- Implements key performance metric to track progress of DI implementation.
- Maintains up-to-date knowledge of the relevant regulations affecting DI.
- Creates and maintains a DI infrastructure for documentation and validation
- Writes protocols for data integrity testing and ensures activities are carried out correctly and meets test criteria/regulatory standards.
- GMP experience within pharma or healthcare regulated environment.
- Experience of implementing DI within either pharma or healthcare, to meet relevant regulations.
- Experience in computer systems validation.
- Experience of educating staff on DI.
- Experience in developing and implementing procedures to ensure compliance to applicable regulations.
Skills and Abilities
- Strong project management skills.
- Good influencing skills and demonstrable ability to build a project plan with buy-in from relevant functions and executed against an agreed schedule.
- Ability to drive improvement and make changes to existing working practices.
- Professional, confident, bright, ability to work on own initiative, self-motivated.
- Good written and oral communication skills.
- Pragmatic and able to adhere to deadlines.
Please click apply now!
Harris Lord is acting as an employment agency on this role.
Keywords: data integrity, GMP, pharma, pharmaceutical, medical devices, IT, Computer Systems, Validation, CSV, computer systems validation
Contact: Josh Hemsley
Keywords: Keywords: data integrity, GMP, pharma, pharmaceutical, medical devices, IT, Computer Systems, Validation, CSV, computer systems validation
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