Validation Specialist

Validation Specialist

12 Months

Barnard Castle

Rate: £43 PAYE / £57p/h Umbrella Max

To lead and organise Validation activities in order to provide an effective validation service and to ensure that all operations, changes and projects relating to processes, facilities, equipment , cleaning validation are assessed and validated in line with regulatory and company requirements.

Key Responsibilities

·      Plan validation activities to ensure customer and business needs are met in alignment with the overall project plans and objectives; accountable for the validation and validation maintenance for Processes, Facilities, Equipment, cleaning projects.

·      Prepare and issue Validation Plans, Summary Reports and other required documentation for a validation exercise.

·      Participate in the Stream Validation Working Party to promote and maintain effective working relationships with Business Unit

·      Present & justify validation scope and documents to both internal and external auditors.

·      Interface with staff in other departments to coordinate resources and complete validation activities in a timely manner.

·      Coordinate the completion of change control activity associated with Validation activities

·      Contribute to the definition and review of new systems and modifications to existing systems to ensure designs comply with current validation standards and are able to be adequately validated and maintained within validated control.

·      Work with the business to promote the value of validation activity in all lifecycle stages of projects, supporting the GPS and embracing the principles of Continued Process Verification

Other Job-Related Skills/Background

·      Knowledge and understanding of a complex and variable equipment range across the site (Technical knowledge of a wide range of appropriate dosage forms – aseptic and terminally sterilized products (vials and syringes), biological, inhalations, dermatologicals)

·      Support a continuous improvement culture within the team through the GPS

·      Demonstrated application of the principles of cGMP and Quality Assurance. Direct experience with Regulators (submissions and/or inspections) is strongly preferred

·      Project management skills, able to hold self and others accountable for delivery against goals

·      Excellent interpersonal skills, including the ability to work across the organization, forming strong partnerships (on and off site) at a technical level, and interact/influence/negotiate effectively at all levels of management and peers.

·      Ability to work well under pressure with tight timelines

·      Excellent consultative, listening, communications and analytical skills (to analyse complex data / information / scenarios and make rational, risk based decisions which are communicated and / or escalated clearly and confidently)

·      Process, Facility, Cleaning, Laboratory systems and equipment validation knowledge.

·      Must be familiar with established documentation practices for validation programs.

·      Knowledge and application of the principle of the Quality Management Syste

·      Experience of risk assessment and the risk based approach to validation

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