VRS Recruitment
Senior Quality Assurance Specialist
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Job Title: Senior Quality Specialist - 12-Month Maternity Cover Contract
Our client is a leading biopharmaceutical company seeking an experienced and motivated individual to join their team as a Senior Quality Specialist on a 12-month maternity cover contract.
About the Role
Working within Global Clinical Sciences and Operations, they are looking for a Quality professional to support and maintain their Quality Management System, ensuring clinical study operations remain compliant with GCP, ICH guidelines and relevant regulatory requirements.
Key Responsibilities
- Work closely with Clinical Operations, Global Quality, Regulatory Affairs and other cross-functional teams, supporting audit and inspection readiness across global clinical functions.
- A key part of the role will involve preparing teams for internal and external audits and regulatory inspections, coordinating responses to findings, and supporting subsequent Corrective and Preventative Actions (CAPAs) through to timely closure.
- Support deviations, change controls, investigations and root cause analysis.
- Write, review and maintain SOPs and other quality documentation.
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Required Qualifications
- Previous Quality Assurance experience within a GCP/clinical trials environment.
- Strong knowledge of GCP, ICH guidelines and clinical research regulations.
- Experience supporting audits, regulatory inspections and inspection readiness.
- Hands-on experience with CAPAs, deviations, change controls and QMS processes.
- Experience writing and revising SOPs.
- Strong investigation and root cause analysis skills.
- Excellent communication and cross-functional stakeholder management skills.
- Experience with Veeva Vault QMS or another electronic QMS would be advantageous.
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Application Information
Apply today to be considered for this highly rewarding opportunity.
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Keywords: Senior Quality Specialist, Clinical Quality, Quality Assurance, QA, GCP, Clinical QA, Clinical Quality Assurance, Clinical Trials, Clinical Operations, QMS, CAPA, deviation, change control, root cause analysis, RCA, audit, inspection, inspection readiness, regulatory inspection, SOP, ICH, Veeva Vault, Veeva QMS, VRS9525MP.
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