Senior GCP Auditor, Global R&D QA

About the role

GCP Consultant - UK

Our client is a large global team of highly qualified GxP consultants. Their consultants strive to provide precise auditing, valuable, in-depth consulting, and training across the industry. With varied educational backgrounds and industry experience, they are subject matter experts. This ensures that they are well suited to objectively advise, evaluate, build or improve your quality systems & compliance.

Key responsibilities include:

• 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
• 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
• Participate and prepare for GCP inspections at client locations and investigator sites, under supervision

Candidate profile:

• Advanced degree in life sciences or scientific discipline
• Extensive 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
• 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

An excellent salary and benefits package will be offered.

Please apply online or contact CHASE for further information on 0131 553 6644.

Reference Number: 56363