- Based in beautiful West Wales
- Up to £30k + up to 10% bonus, private healthcare etc.
- Permanent role
Validation Specialist | Ceredigion - Pharmaceutical
Permanent role
Up to £30k + up to 10% bonus, private healthcare etc.
THE ROLE…
- To deliver all validation activities to support manufacturing at our clients Wales site, ensuring all goods manufactured and services provided by the Company meet the quality requirements of the Company, customers and regulatory authorities
- Accountable for the efficient and timely delivery of Validation activities with respect to qualification of new and existing facilities, utilities, products, processes, manufacturing, packaging and computerised systems
- Responsible for the generation and approval of all validation documentation including but not limited to; installation, operation and performance qualifications, Validation plans and reports.
- Execution of validation testing for manufacturing equipment, utility systems equipment, processes, cleaning validation, product hold times, and any other study identified in accordance with current Good Manufacturing Practices (cGMPs), Good Engineering Practices (GEP) and change control.
- To follow all Standard Operating Procedures (SOP’s), Quality Records (QRs) and Batch Manufacturing Records (BMRs) and to participate in the generation, completion and review of such documentation when required, to agreed timelines.
- Responsible for ensuring that the SVMP qualification schedule for the site is maintained in compliance at all times.
- Supporting the Validation Lead for all Regulatory Inspections, and contributing to any required validation responses from regulatory findings during site inspections.
WHAT YOU WILL NEED…
- Degree in an appropriate scientific discipline or equivalent.
- Strong technical background, gained from a highly regulated environment: pharmaceutical, biotechnology or related industry.
- Previous experience within a validation role essential.
- Provide a sound understanding of the validation and qualification requirements of manufacturing equipment qualification, computer systems validation, utility systems qualification or process validation.
- Excellent understanding and hands–on working knowledge of cGMP, quality and regulatory requirements for commercial material.
- Demonstrated knowledge of cGMPs, MHRA, FDA regulations and current industry practices.
- Experience of front line involvement with Regulatory Inspections.
WHY YOU WILL LOVE WORKING HERE….
- Fantastic company culture
- Work Monday- Friday
- Excellent bonus structure
- Private healthcare, great pension and paid maternity / paternity pay etc.
- Supportive management
- Great location - near the countryside and coast!
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