Computer Systems Validation Specialist

Placed: 02/12/17
Region: Berkshire
Category: Jobs


Content of the advertisement:

Computer Systems Validation Specialist

Berkshire

6 months +



Our client is a true global leader with operations in over 60 countries worldwide, over 35,000 employees with a multi-billion pound turnover. With continued growth, they are seeking a CSV Specialist who will be responsible for the management of their validation during a global piece of work in a fast-paced environment.

Responsibilities / Accountabilities

IS Compliance and Validation

* Author, review, approve validation deliverables.
* Design and manage Validation Master Plan strategies for Global Level Programmes
* Provide CSV oversight to IT programmes assuring compliance in-line with but not limited to: FDA, MHRA, GxP and company standards.
* Ensure that global and local standards regarding Computer Systems Validation are implemented and adhered to.
* Work with business users and IT staff to identify and scope validation related processes.
* Identify compliance risks (with respect to Pharmaceutical industry regulations impacting computer systems) and pro-actively work with the business and IS to address these
* Provide leadership to ensure that computer systems validation activities are implemented consistently across applicable programmes
* Coaching, Guidance and Assurance to project teams on computer systems validation deliverables
* Influence and enforce Good Documentation Practice standards
* Review IS system Change Controls, Incidents and Problems from a compliance perspective
* Conduct periodic reviews of computer systems

Professional Qualifications/ Experience

Qualifications

* Extensive experience in Healthcare/Pharmaceutical business processes including FDA/MHRA approved and validated systems environments.
* Extensive experience of dealing with 21 CFR Part 210, 211, 820 and 21 CFR Part 11 and DEA regulations.
* Extensive experience in CSV methodology and GAMP standards.

Experience -

* Excellent Computer Systems Validation skills
* Support to Global IT programmes
* Design and Manage Validation activities for Global Level Programmes
* Attention to detail when reviewing documentation
* Excellent written and oral communication skills
* Good organisational skills
* Working within regulated industries such as pharmaceutical/healthcare companies
* Up-to-date knowledge of GxP Regulations, industry trends, inspection findings etc.

CSV / GxP / GAMP / Validation / Compliance / Healthcare / TrackWise / Change Controls

Price / Salary: £450 - £480/day