Quality Assurance Officer - pharmaceuticals/medical devices
Scope of role:
You will join an established team of quality assurance professionals who hold responsibility for the development, improvement and maintenance of the QMS in a busy pharmaceutical laboratory.
Key role requirements:
- Assisting with and responding to customer feedback/complaints, in conjunction with the pharmacovigilance team and other departments as necessary
- Preparing for and carrying out internal audits to GxP principles in specific areas of the business
- Coordination of non-conformance reports and CAPA's
- Administering the eQMS
- Documenting and presenting QMS training resources for new and existing staff
- Holding and maintaining KPI data to report on the quality system as appropriate
- Contribution to continuous improvement practices in respect of the QMS
- Organisation and documenting upcoming regulatory inspections with respect to notes and minutes of visits
- Pharmaceutical or Medical Device background - relevant quality experience along with a degree in a relevant scientific discipline
- Proven understanding of GMP or a relevant GxP area, regulatory and accreditation system and quality management
- Competency with process approach and process mapping
- Excellent interpersonal skills and able to work effectively across all areas of the business, using strong influencing and investigative ability
- Technically competent with use of IT packages such as MSOffice, eQMS and advanced Excel skills (pivot tables, design of databases, dashboards)
- Able to plan and deliver presentations including training to a variety of internal audiences
Does this describe your next job move?
Are you undertaking a similar Quality role in pharma or medical devices, and want the next challenge?
Then apply now - by attaching your CV in Word, or contact Bec Johnston for further information:
email@example.com / 01223 607858
your application has been submitted