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Senior QA Officer in Hertfordshire
Senior QA Officer required by leading independent pharmaceutical company based in Hertfordshire. In this key role you will be responsible for the development, improvement and maintenance of the Quality Management System (QMS) across multiple sites.
Handling customer complaints.
Leading and performing internal audits across a variety of GMP / GXP areas.
Initiating and coordinating non-conformance reports and/or CAPAs.
Acting as the administrator of eQMS.
Preparing and presenting training material in QMS processes.
Coordinating, monitoring and preparing KPI reports.
Continuous improvement of QMS.
Support QA activities at other company sites such as validation activity and project support.
Planning, managing and delivering projects to meet the demands of the business.
Organising and coordinating activities for regulatory inspections.
Degree in a relevant scientific subject such as Chemistry, Biology or Pharmaceutical Science.
At least 5 years of experience working in Quality Assurance within the Pharmaceutical or Medical Device sectors.
Full understanding of GMP (or other GxP area) and regulatory and accreditation systems and quality management systems.
Validation experience or knowledge including Process, Equipment, Cleaning and computer systems.
Good understanding of process approach and competent in process mapping.
Ability to take decisions, to analyse information and prepare coherent investigative/technical reports.
Ability to plan, organise and manage multiple projects.
Internal auditing experience.
Exceptional communication skills.
Full Driving Licence essential.