NRL’s client based in Ulverston is looking to recruit a Quality Validation Specialist for an initial 12 month contract on a PAYE basis.
About the role
- To communicate with all other project team members.
- To organise and lead Validation working parties, providing a timely validation co-ordination service to the Project Manager and Project Sponsor.
- To provide information to the Validation and Project Team on the current regulatory and company standards that must be met to maintain compliance.
- 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 GSK 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, etc.
- Ensure that the Project Team is aware of the latest guidelines on validation, control of change, etc.
- Advise on cleaning validation.
- 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 ensure that all appropriate Validation staff are kept fully aware of the project, including:
- Manage the interface with all Quality functions to ensure that appropriate personnel are involved where relevant.
- Ensure that process related information and proposed process changes are communicated
- Regulatory strategy
- Project programme, including validation and commissioning plans
- Suspension or changes to existing routine operations
- Plant layout changes/implications
What you will need?
- HND level qualification or equivalent in either a science or engineering subject
- expert knowledge of validation in alignment with QMS, cGMP, GQLP and cGxP requirements
- Abroad multidisciplined knowledge of computer hardware, software, relational databases and other technology
- Experience in a regulated quality driven process environment
- Specialist knowledge of validation