Job Title: Validation Specialist
Reporting to: Validation Team Leader
Responsible for (staff): None
General Purpose of Role:
- We are looking to for a dynamic individual to join on a permanent basis to ensure the complete delivery of fully compliant qualification and validation of equipment, software, facilities, cleaning processes and operational manufacturing processes on site. To ensure the complete delivery of fully compliant Product Quality Review reports and any follow up actions.
- The successful candidate will be responsible for the preparation, review and approval of validation master plans and validation plans. Preparation, execution, review and approval of qualification and/validation documentation (specifications, protocols, reports etc.) in relation to instrument, equipment and utilities etc. The review and approval of third party generated protocols and reports along with the review and execution and approval of factory acceptance tests and site acceptance testing activities.
- Preparation, review and approval of validation master plans and validation plans.
- Preparation, execution, review and approval of qualification and / validation documentation (protocols, reports etc.) in relation to instrument, equipment, facilities, utilities, processes and software.
- Review and approval of third party generated protocols and reports.
- Review, execution and approval of Factory Acceptance Tests.
- Review, execution and approval of Site Acceptance Tests /commissioning.
- Evaluation of equipment / service providers.
- Management of validation related deviations and change controls.
- Where required, provide assistance to other roles within the Technical Transfer or CI groups as required.
- Candidates should hold a first degree in Chemistry, Pharmacy, Microbiology or allied sciences or significant industry experience that is comparable.
Previous Work Experience:
- Experience in a similar role in the pharmaceutical industry with up to date credentials relevant to both investigational (clinical trial) and marketed (commercial products).
- Familiarity with ISPE cleaning and cross-contamination guidance.
- Experienced in completing PQRs,
- Experience in IT validation and configuration desirable.
- Experience of leading projects would be desirable.
Specific Knowledge / Skills Competence:
- Must be a completion driven individual, with the attitude to drive projects to completion in considerable detail.
- A proven ability and desire to continuously improve and have the attitude to drive projects to completion in considerable detail. Must have strong influencing skills and be able to initiate and implement change and achieve the buy-in of all staff.
- Excellent communication and interpersonal skills are essential as the role involves dealing with a wide range of individuals and groups.
- Proven ability to plan effectively, by taking a long-term view and developing structured action plans to meet business objectives.
- Must be able to effectively manage multiple tasks simultaneously.
- Be able to self-manage, multi-task and be self-motivated.
April 1, 2016