Quality Assurance Associate

Department: Quality Assurance and Regulatory
Reports To: QA and Regulatory Manager


Job purpose 

  • Verify all operations are compliant with internal procedures and regulatory requirements. The Quality Associate will 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
 

Duty and responsibilities

  • 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.
  • Troubleshoots existing practices and deviations using quality tools to solve day to day problems as they arise.
  • Product release.
  • Generation of batch numbers and certificate of analysis.
  • Receipt, acceptance, and approval of raw materials.
  • Maintain NHBA and Warehouse Stocks.
  • Support dispatch and ensure shipments and documentation is complete for dispatch
    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.
  • Performing audits to monitor compliance of internal operations and inter procedures and regulatory requirements via internal audits.
  • Involvement in preparation of customer audits.
  • Support with Purolite’s vendor management program.

Required qualifications and experience

  • 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 organized and possess excellent interpersonal and communication skills, with a good attention to detail.
  • Support development and maintenance activities of quality systems, reporting KPI’s; driving continual improvements and an understanding of commercial ‘Costs of Poor Quality’.

Additional Information

Employee’s benefits:

There is a life assurance which is 4 x the salary.

To apply please send your C.V. to ukadministration@purolite.com.