Computer Systems Validation Specialist

Adepto Technical
08 Apr 2018
20 Apr 2018
Contract Type
Full Time
Computer Systems Validation Specialist - Permanent - Pharmaceutical - Wiltshire

Our client is a leading biopharmaceutical organisation. Due to continued growth they are seeking a Computer Systems Validation Specialist on a permanent basis at their facility based in Wiltshire, UK.

To lead and execute CSV validation activities of computerised systems and associated equipment in accordance with current regulatory requirements.
To minimize business risk associated with the processing and storage of electronic documentation ensuring continuity over the equipment and product’s life cycle.
Take the lead in computer system validation and compliance, manage and deliver specific Validation Projects according to the business priorities, including work scheduling and supervision of junior members of staff.
Comfortable working alone or within the matrix management system.
Continuous improvement of validation systems and procedures to ensure efficiency and best practice within the industry and to stay abreast of changing regulatory expectations.
Write, review and approve validation documentation including protocols and reports and manage the timely closure of any discrepancies or non-conformities.
Providing a reliable service to our internal customers to ensure that timescales are met and work is carried out to meet expectations.
Maintaining the ongoing compliant status of computer systems associated with equipment, facilities and utilities by involvement of the scheduling of activities.
Communicating validation activities with our internal and external customers and working with them to resolve problems and conflicts.
Undertake all work in accordance with Code of Safety Practice and site Quality Policies.

Substantial experience of generation, execution and review of validation protocols, reports and technical documents.
Experience of validation life cycle activities for computerised systems.
Substantial practical experience of working within a GMP quality system.
Experience of dealing with internal customers, identifying and delivering work programmes, reporting progress, dealing with issues to ensure customer satisfaction
Experience of supervising junior staff.
Practical experience within a biopharmaceutical manufacturing environment.
Experience of the validation of production processes.
Practical experience dealing with internal and external, including regulatory agencies, inspectors and auditors.
Experience of working at suppliers sites including outside UK.
A thorough understanding of the equipment validation life cycle activities for pharmaceutical manufacture and testing equipment.
A comprehensive understanding of EU and FDA regulatory requirements relating to validation including (but not limited to) UK/EU GMP Annex 11 and 21 CFR Part11.
An understanding of GAMP processes.
Technical understanding of computerised systems including PLCs, SCADA, networked systems, laboratory systems, databases, layered software as used in a GxP environment.
Understanding of the implementation risk in a site wide validation approach.
Understanding of techniques employed to qualify legacy systems

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