Description
Optimus Search are an industry leading Recruitment Consultancy currently working with some of the world's most renowned companies.My client is a leading Pharmaceutical company based in Luton, together we are looking for a Validation Specialist to join their team on a 6-month contract.
Ideal applicants will have a minimum 5 years' experience in a similar role.
My client would like to interview candidates for this role immediately. If you are interested in finding out more about this role, then please send your CV over to , and we can arrange a time to talk in more detail.
Tasks & Requirements;
- Strong industry knowledge, project proficiency, and autonomy expected. Considered a validation Subject Matter Expert (SME) in the areas of plant automation and process control systems, QC Chemistry and microbiology systems, metrology business systems and IT infrastructure.
- Defining validation strategies and complete oversight through the implementation of validations plans for site based computer systems.
- Plan computer validation projects and track execution of validation activities versus project timeline. Manage and plan the work of the internal and contract resources.
- Perform change control assessments and write/review validation plans, qualification protocols and summary reports. Manage the execution of qualification protocols and review test results.
- Expertise in Software Development Life Cycle (SDLC), 21 CFR Part 11, EU's Annex 11, and GAMP 5 requirements.
- Lead risk assessments to identify critical SDLC activities and deliverables during the implementation and validation of various computer systems.