Validation, Risk & Compliance Consultant (GxP, SAP, GAMP 5)

Location: Surrey, England
Job Type: Contract
Specialisation: IT
Salary: Negotiable
Reference: 71800-ITENG-KSB_1528795634
Contact: Kelvin Ball
Email: email Kelvin
VALIDATION - RISK - COMPLIANCE - GxP - PHARMA - GAMP 5 - SAP

Our client, a leading Pharma company based in Surrey, has the opportunity for a Validation & Compliance Consultant to join them on a initial 12 month contract.

Key skills needed for the role are:

* Very strong experience with Validation, Risk and Compliance
* Strong knowledge working with GxP
* Good knowledge of GAMP 5
* Good experience of SAP
* Strong experience with SOX / JSOX
* Used to, and comfortable, working autonomously
* Be able to make timely risk based decisions in a very fast moving programme
* Have the confidence and ability to take it back to Best Practice, rather than just taking the easy option

Key Objectives

* Act as a subject matter expert with respect to GxP, JSoX, Data Privacy and other regulatory domains impacting the Apple program
* To provide advice on the application of Policies and Procedures with respect to IS systems implementation and compliance
* To provide advice on compliance with global regulations pertaining to GxP regulations
* To support the planning of compliance activities including validation in accordance with risk
* To oversee the compliance activities of the Apple program through practical, compliant advice and document review
* To evaluate compliance risks and deviations in order to minimise the regulatory impact to the client
* To provide training to project personnel, internal and external to ensure that policies and procedures are understood and applied effectively
* To liaise with compliance groups including QA to ensure that approaches, risks and issues are fully understood and acceptable
* To provide mentorship to external parties to ensure they fully understand the client's policies and procedures
* To ensure that a risk based approach is taken where proportionate effort is applied in accordance with business and regulatory risk