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Manager , Clinical Quality Assurance Job
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| Employer Name: BiotechCrossing |
SpiderID: 2355149 |
| Location: Ridgefield, Connecticut |
Date Posted: 7/9/2008 |
| Wage: |
Category: Biotech |
| Job Code: 6025721 |
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Job Description:
Organize and implement an International Clinical QA activity plan for assigned products. Plan and conduct GCP audits of clinical research activities to assess compliance with GCP, ICH, local regulations, (including assessment of compliance with FDA requirements and guidances on computerized systems), protocol, and company SOP/WI; GCP specialist has responsibility for conduct of audits at clinical investigator sites and CROs, both domestic and international; internal product and system audits. Computer System (CSV) Validation specialist has responsibility for conduct of audits of computerized systems used in clinical research, both internal and external. Identify, evaluate, and recommend solutions to problems identified in the performance of GCP audits. Prepare clear and concise written reports of audit observations, including an assessment of compliance. Assess adequacy of auditees action plan. Conduct follow up activities as needed to monitor corrective actions. Participate in local initiatives involving GCP compliance, as assigned. Participate in meetings/teleconferences with International Clinical Quality Assurance group. Participate on ICQA working groups and projects as assigned. Maintain professional expertise and knowledge of local and international regulatory requirements. Assist with GCP training internally of Medical /DRA and externally of investigators and vendors. Provide guidance on GCPs and requirements surrounding computerized systems to Medical/DRA on daily basis as needed. REQUIREMENTS: BS/BA in scientific or health related field. Minimum of 8 years pharmaceutical industry experience. Six years auditing experience with minimum of 4 years specific to GCP auditing (CSV Specialist - 4 years specific to medical area) or 6 years as Senior level CRA with on site monitoring experience (CSV Specialist- 6 years of IT/validation experience).
For more information, please click here to visit us at BiotechCrossing
For further information, please visit us online at http://www.biotechcrossing.com
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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: - |
Company Type: Employer |
| Company: BiotechCrossing |
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| City: Pasadena |
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| State: California |
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| Zip: |
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Web Site: http://www.biotechcrossing.com
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