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Vacancy details
Vacancy description:
Job Code:
(Senior) GCP Specialist
Job Title:
(Senior) GCP Specialist
Job Category:
Regulatory And Drug Safety
Contract:
Permanent
Discipline:
Any Discipline
Country:
United Kingdom
Location:
Wiltshire
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
24 Jun 2008
(Senior) GCP Specialist
Qualifications: Bachelors degree in Life Science/Biomedical discipline (and/or equivalent)
At least 2-4 years direct experience with GCPs or clinical research auditing, and/or proficiency in all CQA auditing skills and demonstrated excellent knowledge and performance.
At least 2-4 years experience in pharmaceutical, biotechnology, CRO industry, or equivalent preferred.
KEYS SKILLS AND BEHAVIOURS
Excellent oral communication skills (German and English)
Computer literacy
Clear understanding of GCP regulations and guidelines
Attendance at one external seminar or course yearly directly related to responsibilities
Participation in CQA mentor program
Ability and willingness to deliver presentations
Responsibilities:
Manage CQA projects as a Project Leader with responsibilities for contract / quality plan execution, pricing/budget management, and timelines for CQA deliverables
Develop and implement Quality Plans in accordance with contractual specifications or internal quality program
Perform contracted and non-contracted internal, field, and Sponsor compliance audits including, but not limited to: file audits, site audits, data audits, and process assessment activities
Communicate findings to project team through written and oral reports
Consultant to company personnel on the interpretation of company SOPs, ICH GCP Guidelines, and applicable regulations
Assist with generation of client proposals
Attend/Present at Investigator Meetings
Perform specific CQA management duties as assigned by management
Host or co-host assessments and audits by sponsor companies and ensure appropriate corrective actions on observations
Assume responsibilities of a Process Owner, as assigned by management, including the drafting, training, implementation, and ongoing monitoring of CQA processes and procedures
Department: Global Clinical Quality Assurance
Location: Chippenham United Kingdom
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