SRG are working with a global name in the pharmaceutical industry to help them find a QA Compliance Officer.
If you have QA and/or Compliance experience from a GMP environment then this could be a great next step for you.
The company offer an excellent benefits package and flexible working.
The Role:
If you have QA and/or Compliance experience from a GMP environment then this could be a great next step for you.
The company offer an excellent benefits package and flexible working.
The Role:
- Supporting the quality management system (QMS) and related activities such as QMS monitoring, Qualification of Vendors, Audits (Self-Inspections, Vendor Audits, Customer Audits)
- Support updates to regulatory agency registrations where required
- Support tracking of site compliance commitments and follow up actions
- Liaising with teams across the site to support compliance and drive improvements
- Support and track regulatory findings and trends
- Support review of procedures and other QMS related documentation according to internal guidelines and UK/EU/US/ICH and other region specific guidance
- Lead Quality Management Review meetings highlighting areas of concern and working to support and track follow-up actions
- Support quality related investigations, assist in the development and approval of effective CAPAs in order to resolve product, audit and customer issues
- Support effective pre-audit preparation and post audit follow up of customer audits and regulatory inspections
- Escalate any significant breaches of quality or regulatory compliance to Quality Management
- Degree in a relevant scientific, engineering or business discipline and/or relevant industry experience
- At least several years' experience within Quality Assurance working to GMP guidelines
- Must be highly proficient with computer programs such as MS Word, Excel and PowerPoint.
- Experience of performing self-inspections or audits of 3rd party suppliers
- Experience of working within a Quality Management System e.g. completing or reviewing QMS documentation (SOPs/Deviations /Investigations /CAPA)
- Organised and attention to detail
- Strong communication skills across all levels