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Cardiff (Full Time, Permanent) £25,000 / Year (Company pension & life assurance)
Quality Associate - Cardiff
Purolite is the 2nd largest ion exchange manufacturer globally and is the only company dedicated to resin technology. They have been rapidly expanding into the life sciences market and have a pilot scale facility in Llantrisant which has been operation since 2014 manufacturing agarose based chromatography resins.
•Verify all operations are compliant with internal procedures and regulatory requirements. •Support the development and implementation of the QA systems during the scale-up and manufacture of products that service global pharmaceutical markets. •Ensure the needs of both internal and external customers are met through efficient use of the quality processes and the systems available. Where required there may be the need to support validation, inspections and system development as the site evolves. •Act as first line support and system administrator for the company’s electronic management system Q-Pulse. •Assists with development, implementation and maintenance, as needed. •Coordinate customer complaints and regulatory requests ensuring On Time in Full completion. •Troubleshoots existing practices and deviations using quality tools to solve day to day problems as they arise. •Participation in the change control process to ensure changes to processes, systems, equipment and facilities are appropriately assessed and implemented. •Participates in both group and cross-functional process improvement and development initiatives. •Support development and maintenance activities of quality systems, reporting KPI’s; driving continual improvements and an understanding of commercial ‘Costs of Poor Quality’. •Coordination of MSDS’s for Life Science and Agarose product ranges. •Performing audits to monitor compliance of internal operations with internal procedures and regulatory requirements. •Involvement in co-ordinating 3rd Party audits, co-ordination of responses and follow up of corrective and preventative actions.
•A scientific degree, or equivalent. •Minimum of 3 years’ experience in a global regulated environment with a sound understanding of quality system requirements. (cGMP and ISO9001 advantageous). •Must have software and technical skills; all Microsoft Office applications. (Q-Pulse or other electronic QMS software an advantage). •Internal Auditing experience to ISO9001 requirements (cGMP advantageous). •Confident and flexible working attitude; work effectively within an environment that has quickly changing priorities, and deadlines to satisfy customers both internal and external to the organisation. •Must be organised and possess excellent interpersonal and communication skills, with a good attention to detail.