Computer Validation Consultant

Ref No. EMP404328
Salary £400 - £425/annum
Location Brentford, England
Start date ASAP
Job type Contract (6 Months)
Job Status Now Interviewing

Introduction

An industry leading healthcare manufacturer requires a Computer Systems Validation Consultant to join their business on an initial 6 month contract based in Brentford.

Important

Computer Systems Validation, Pharmaceutical Industry

The Job

An industry leading healthcare manufacturer requires a Computer Systems Validation Consultant to join their business on an initial 6 month contract based in Brentford.

Job Profile:

To manage validation of strategic computer systems such that they are validated in accordance with company and regulatory requirements and are maintained in accordance with those requirements.

* Planning and managing validation of high cost, complex, strategic systems using risk based approaches to ensure systems are fit for purpose, that significant risks are identified and mitigated, and that the approach and rigor of validation is in proportion to the risks the systems present to regulated business processes.
* Preparation and approval of validation documentation or management of the process (fulfilling the Quality Assurance role) in accordance with the relevant processes (e.g. Quality Management System)
* Validation planning for projects including project interaction with IT, software suppliers, and outsource companies.
* Project problem resolution/avoidance - this typically involves ongoing interaction with IT Managers/Directors, site Validation Managers and senior management of suppliers.
* QA Support of the deployment and maintenance of multiple (3-7) global projects including responsibility for the developing solutions that maintain compliance and keep validation on schedule and on budget
* Managing the collection of data for the assigned KPIs and Service Level Agreements
* Providing Compliance oversight and training to internal and external suppliers, e.g., IT teams outside GMS and globally sourced providers, as applicable
* Ensuring completion of Periodic Compliance Review activities and negotiating the required corrective actions
* Ability to work under minimal supervision; Assess priorities and work well under pressure in a fast paced environment
* Previous involvement within the Pharmaceutical environment (GMP and/or 21 CFR part 11)
* Strong verbal and written communication skills
* Focus on Data Integrity and Audit Trail Review

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