Oxford (Full Time, Permanent) £40,000 / Year (c£40k+pens+health+life assurance)
Technical Quality Assurance Specialist / Quality Auditor - Oxford, Oxfordshire
Due to expansion there is now a vacancy for a Technical Quality Assurance Specialist / Quality Auditor to join a global-leading pharmaceutical company in Oxford, Oxfordshire. Salary package for the Technical Quality Assurance Specialist / Quality Auditor is c£40,000 pension healthcare life assurance.
Overview of Main Job Functions:
• Maintain the site in compliance with worldwide quality and regulatory standards and requirements for Design, Validation and Software QA, providing quality assurance expertise
• Assist the Technical QA Manager in the development and implementation of procedures to ensure the effectiveness of the Quality System
Duties and Responsibilities:
• Review and approve Quality Records for compliance with Regulatory requirements, Quality System requirements, quality and business objectives
• Maintain and improve the Quality System, the standard of documents and the review cycle turnaround times
• Establish effective partnerships with Project Owners in order to define and implement effective plans for new product and on-market design change projects
• Represent Technical QA across other departments and teams
• Maintain the Quality System policies and procedures that govern the Department’s responsibilities. Provide expertise and training to the site in order to promote adherence to regulatory, Corporate, Division and site requirements
• Ensure compliance with the site Validation Master Plans
• Provide input to Departmental and Site Management Review Quality metrics
• Ensure appropriate storage of Quality Records
• Provide support to wider quality activities based on product and process knowledge achieved through evaluation/ understanding of end user needs, design control outputs, on-market surveillance activities and CAPA investigations
Skills and Experience Required:
• Qualified to degree level or equivalent experience in an appropriate scientific discipline
• Relevant previous experience of the development and/or manufacture of regulated products
• Familiarity with cGMP and/or ISO Quality System requirements
• Knowledge of some of the following areas: Design and Development; Validation of Production Processes; Software Validation.
