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
* 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
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