Senior QA Officer - Pharmaceutical Manufacturer
Our Client is a very successful pharmaceutical company. They are now seeking a Senior QA Officer. This position is a full-time permanent role and will be based near Hitchin in Hertfordshire.
Job Profile
- An opportunity has arisen for a Senior QA Officer to join the Quality Assurance team
- The role will be responsible for the development, improvement and maintenance of the Quality Management System (QMS)
Key Areas of Responsibility
- Handling quality-related customer complaints in conjunction with PVG and other departments as required
- Leading and performing internal audits across a variety of 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 on the Quality System
- Contributing to continuous improvement of QMS in line with overall improvement and harmonisation of the Group QMS.
- Support QA activities at other sites i.e. validation activity, project support may result in up to 5 days / month working at other sites.
- Planning, managing and delivering projects to meet the demands of the business
- Organising and coordinating activities for regulatory inspections
Qualifications / Experience
- Experience working in QA and technical roles within a Pharmaceutical / Medical Device environment along with a degree or equivalent in a relevant scientific discipline.
- Clear understanding of; GMP, or any other GxP area, regulatory and accreditation systems and quality management
- Understanding or experience of all types of validation i.e. 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
- Competent in computer packages, Microsoft Office, and electronic quality management package (preferred) and advanced excel skills to be able to create pivot tables, design databases and dashboards
- Competence in preparing presentations, delivering training to a variety of internal audiences
- Ability to plan, organise and manage multiple projects
- Emotionally resilient with the ability to work under pressure with a can-do attitude
- Effective communicator with the ability to build strong working relationships
In return our client is offering a competitive basic salary plus comprehensive benefits for the successful Candidate
Please send your C.V to Lorraine Roger, Director at Atom Recruitment Ltd...... click apply for full job details