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  • Job reference: RMS0168035

Senior Quality Leader (Validation)

  • Sector: Oil & Gas
  • Location: Aberdeen
  • Job type: Contract
  • Date posted: 19/05/2016
This vacancy has now been filled.

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The Company:
Our client is a leading engineering contractor and project integrator for the nuclear industry. They have been at the heart of the UK nuclear industry for more than 50 years. During that time they have designed, manufactured, installed and commissioned a wide range of nuclear equipment and plant for both the power generation and defence markets.

The Role:
The Validation Engineer will be required to take validation & compliance matters from design reviews, reporting, through to IQ protocol writing & execution, providing handover packages.

Validation Representative Responsibilities
(Some of these activities may be carried out with the Main Process Contractor dependent on the specific project and contracting strategies agreed for the project).
• To communicate with all other project team members.
• To prepare and issue Validation Master Plan(s) and Summary Report(s).
• Support the preparation and issue of validation documentation associated with Validation, as appropriate for each validation exercise.
• To ensure all Validation activities and documents are authorised and appropriate compliance approval is gained.
• To ensure that all Validation activities are carried out and reported in a timely manner.
• To compile a Validation Master File for each Validation exercise or group exercises as appropriate.
• To assure compliance through auditing.
• Through effective communication and training initiatives develop staff within Project and Validation Teams to ensure that validated projects are carried out in accordance with end clients Policies and Procedures.
• To sign off Project Change Controls to confirm no adverse effect on GMP or validation status.

The Validation Representative has a number of key responsibilities to the Project Team:
• To ensure that all Validation issues are addressed through all phases of the project life cycle, across all appropriate disciplines and include:
• In conjunction with the Quality Assurance Representative, providing a proactive contribution to, and act as a focus for, questions relating to GMP, cleaning, analytical information, specifications, control of change, IQ , OQ , DQ etc...
• Ensure that the Project Team is aware of the latest guidelines on validation, control of change, etc.
• To ensure that all activities within this responsibility are undertaken in a timely manner to allow the smooth progression throughout the Project from Initiation to Handover.
• To influence the design, to ensure that the new or modified plant is capable of being operated appropriate to the process to the appropriate quality.
• To ensure that all Validation protocols are produced and implemented through all phases of the project including:
• Provide an outline of likely validation requirements for the project and take a lead role in the preparation of validation master plan.
• Ensure that the project design and documentation meet the required standards by an appropriate level of auditing.
• Monitor progress against plans and protocols and provide key milestone reviews.
• Approve progression to the next validation phase.
• Report deviations or delays and support development of checklists and test rationales.
• Meet the requirements of any registration or regulatory bodies.
• To consider the implications of the project on future Validation resource requirements, including:
o Assess the impact of the higher production levels on Validation resources and facilities and identify any additional equipment and/or facilities required.
o Consideration of Validation requirements, including analysis equipment, and staffing levels

At Project Handover, to allow the plant to be put into operation:
• Produce the final Validation Summary Report
• Ensure all Validation documentation is issued
• All validated procedures are in place
• Work in close liaison with the Commissioning Manager

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