Computer System Validation Specialist

Computer System Validation Specialist

Fully remote

6 months initially with possible extension

£590 per day – via umbrella

Working under the oversight of the Quality & Validation Manager: 

With a background in both Business and Tech Change Management within a regulated large Corporate environment, the successful candidate will work alongside the Business and Tech teams delivering global change programmes, ensuring Company and Regulatory commitments for GxP applications and data are met. 

Responsibilities

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) 

·        Monitoring project and/or support activities 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

·        Providing and/or facilitating quality assurance oversight for the automation of business process associated with pharmaceutical manufacture and distribution

·        Project problem and post deployment incident identification/resolution/avoidance; typically involving ongoing interaction with management teams within Tech functions, site and local operating company Quality organisations, and Third Party suppliers/service providers

·        Participating in the deployment, maintenance and inspection support of multiple global projects including responsibility, with management oversight, for the developing solutions that maintain compliance and keep validation on schedule and on budget 

·        Ensuring issues/risks are identified, mitigated and/or escalated for items that could adversely impact quality compliance associated with projects/systems 

·        Provision of performance measures to drive performance and continuous improvement 

·        Performing periodic compliance reviews of Tech systems

·        Identification of simplification opportunities in the process and ownership of making proposal and (where agreed) delivering upon them.

Skills & Experience

·      Understanding of pharmaceutical manufacturing and distribution regulations, guidelines, principles and expectations 

·      Demonstrated ability to interpret and apply company guidelines, principles and expectations such that systems are validated in proportion to the risk they present to patient safety and product quality.

·      Broad experience in providing validation, deployment, change management, and inspection support of large, complex, computerised systems

·      Technical knowledge to support quality and validation decision making for GxP analytical, manufacturing, distribution and IT computerized systems 

·      Experience managing the delivery and/or decommissioning of Tech systems in a Pharma or similar ‘heavily’ regulated environment against immoveable deadlines, utilising a risk-based approach.

·      Technical and business process knowledge to support quality and validation decision making for GxP Tech Systems.

·      Demonstrated ability to manage multiple projects

·      Demonstrated ability to handle multiple priorities within and across projects and complete work within agreed timescales

·      Effective communicator with ability to collaborate and form strong partnerships within teams and diverse stakeholders/customers that result in "win-win" outcomes to achieve business goals and objectives

·      Experience in coaching/mentoring various personnel in quality & validation principles and activities

·      Working knowledge of ‘New Technologies’ within a regulated environment: 

o     Robotic Process Automation

o     Data Analytics

o     Biometrics and Electronic Signatures 

o     Cloud (IaaS, PaaS, SaaS) 

o     Automated Testing Tools 

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