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Vacancy details
Vacancy description:
Job Code:
13669
Job Title:
Senior Quality Assurance GCP Auditor
Job Category:
Regulatory And Drug Safety
Contract:
Permanent
Discipline:
QA
Country:
United Kingdom
Location:
Berkshire
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
07 Aug 2008
This is an outstanding opportunity for an experienced QA Auditor with GCP experience in clinical trials. Our client, a global CRO that manages all aspects of clinical development programmes for pharmaceutical and biotechnology companies, is seeking a Senior QA Auditor at their office in Berkshire to provide on-going assessment of the status of the compliance of the company’s European operations with regulatory, procedural and contractual requirements.
PRINCIPAL RESPONSIBILITIES include:
• Conducting, reporting and following-up audits of projects and operational areas in accordance with approved schedules, procedures and formats. Emphasis placed on, but not limited to:
- Investigator site audit
- Trial master file review
- Vendor audit
- Internal process audit
• Scheduling and managing personal workload in alignment with central plan and departmental objectives.
• Maintaining current awareness of regulations and guidelines relating to the conduct of clinical trials in Europe.
• Advising operational staff with regard to regulatory requirements and appropriate corrective and preventive actions in response to audit findings and the remediation of operational situations.
• Hosting and reporting on sponsor audits and regulatory inspections of the Company in Europe, in accordance with approved procedures and management direction.
QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
• BS/BA degree or equivalent in a scientific or healthcare discipline.
• Extensive experience applying GCP in a clinical trials environment, either as monitor or auditor.
• Strong knowledge of GCP regulations, legislation and guidelines, plus awareness of other GxP requirements relevant to the conduct of clinical trials.
• Understanding of data management practices would be an advantage.
SKILLS & PERSONAL REQUIREMENTS:
• Must be fluent in written and spoken English, with appropriate medical/technical vocabulary.
• Fluent in English plus working knowledge of at least one Eastern European language would be an advantage.
• Computer literacy essential.
• Willing and able to travel internationally for a minimum of 50% of time.
BENEFITS OF THE ROLE: This is an outstanding opportunity to join a team of people who are committed to a process of continual improvement to increase efficiency and maintain their exceptionally high standards for the improvement of global health. The role offers an excellent salary and working conditions, career development opportunities and comprehensive benefits which may include, subject to eligibility, pension, life assurance, permanent health insurance and private health insurance plans and childcare vouchers if applicable.
Fforde is a uniquely specialised recruitment agency/business for the pharmaceutical, clinical research and biotechnology sectors.
KEY WORDS: Clinical Auditor, Senior Quality Assurance Auditor, QA Auditor, Quality Assurance, QA, Drug Development, Drug Safety, Oncology
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