Our client is a large pharmaceutical process plant, employing up to 1000 staff at it’s facility in Elstree, Hertfordshire.
They require an Analytical Method and Equipment Validation Specialist to;
- Manage approved projects to establish new and modified analytical methods in the Control Laboratory
- Perform validation and re-validation of laboratory equipment within the Control laboratory
- Provide analytical support for troubleshooting and non-routine test methods in the QC Chemistry section.
Knowledge, Skill and Experience Required:
- A scientific degree science and/or substantial relevant pharmaceutical /laboratory experience.
- Experience of Analytical method and equipment validation and an understanding of the principles involved in the validation cycle including DQ, IQ, OQ and PQ.
- Extensive knowledge of a wide range of analytical methods and techniques and experience of troubleshooting analytical methods and equipment issues.
- Experience of planning and project management, preferably involving the supervision of staff.
- An understanding of the regulatory and quality issues affecting both pharmaceutical product manufacture and Laboratory Method and equipment validation.
- An ability to recognize and implement necessary changes to existing procedures in order to modify existing company workflow patterns.
- Experience of people and resource management.
Major Challenge of the Job:
- To ensure that Control laboratory remains compliant with respect to analytical method and equipment validation.
- To ensure that all analytical method and equipment validation is adequately planned and that projects are completed in a timely manner.
- To ensure that all validation documentation is completed according to company policies and procedures and is managed in a manner that is both secure and readily accessible for audits and inspections.
- To provide analytical support for troubleshooting and non-routine test methods in the QC Chemistry section and to ensure that where problems occur these do not unnecessarily impede the functioning of the QC Chemistry section.
If you meet the above, and would like to know more, please apply, or contact Tim Hill at Technical Placements.
Full job description available on request.