Impel Talent are currently partnering with an industry leading Clinical Qualiity focused Consultancy who are currently looking to consolidate their auditing function. They are looking to secure a Senior Clinical Quality Auditor for EU operations.
The experience you need to bring:
- Advanced degree in life sciences or scientific discipline
- 5 – 8 years total QA GCP experience (Pharma or Biotech or Medical Devices)
- Regulatory inspection readiness experience (working in a team but not the lead)
- Direct hands-on experience of working on audit planning, execution and delivery (at least 4 years)
Soft Skills you need to possess and practise:
- Ability to identify issues and offer solutions to problems in a pragmatic way
- Good attention to detail, with the ability to see the ‘big picture’
- Highly professional and self-motivated, experience working from home
- Ability to assimilate and analyse information rapidly
- Confidence to work alone or in a team
- Able to communicate easily with Operations team members as well as quality team members
- Articulate issues and situations succinctly
- Assertive
The successful candidate will be responsible for:
Auditing
- Coordinate and conduct internal system audits and external investigative site/vendor audits
- Create, maintain, and revise organisations Standard Operating Procedures, forms, and templates
- Evaluates responses to audit reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution
QA Systems
- Coordinate, conduct, track, and resolve Corrective Action / Preventative Action (CAPA) completions
- Ensures that systems used in QA are properly maintained (e.g., QA audit records, training records)
- Performs study sign-off including but not limited to QA statement preparation (internal/external) and report finalization
- Help in developing training materials and applicable tests and guides
- Creating content such as blogs and case studies and whitepapers per instructions from the Director of Operations
Inspection Readiness
- Participate and prepare for GCP inspections at client locations and investigator sites, under supervision
Quality Consulting
- Work alongside experienced quality consultants to understand the issues and problems of clients that need solutions
- Prepare and deliver assigned tasks per Project Manager/Project Director guidance and instructions.
For further information please contact Paul Shaw at Impel Talent at 07549 024401 or e-mail paul.shaw@impeltalent.com
