Description
Requirements and Responsibilities:-
Minimum of 8 to 10+ years' experience in the pharmaceutical/biotechnology industry. -
Assist with development of the audit strategy and programs. -
Accomplished knowledge of global and local GCP regulations. -
Minimum of 7+ years' auditing in one of the following areas: GCP, GLP, GPvP - Expert knowledge of technical concepts required for all aspects of GCP Auditing, to include all types of GCP audits; e.g., Study Sites, Vendors, essential study documentation
- Solid understanding of domestic and international pharmaceutical/Biotechnology auditing standards
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Clinical Quality System and Clinical computerized systems; e.g., EDC, IxRS, etc. - Provides oversight and directs training of CQA staff in all aspects of the quality management function; especially as it relates to conducting and hosting auditing..
- Identify/monitor GCP compliance risks;provide guidance on mitigation/management of such risks.
- Lead and/or support GCP inspection readiness and inspection management activities.
- Represent CQA in Study Management Team, GCP Compliance Committee, and Clinical Quality System review and improvement teams.
- In collaboration with the Director, CQA, ensure that appropriate Standard Operating Procedures are in place
- Appropriately and expeditiously escalate GCP compliance issues.
- Communicate audit results to management and auditees through written audit reports.
- Assist with training/orientation/qualification of new CQAAuditing staff
- Travel required up to 35% as needed (travel may be domestic and international)
To find out more about Real please visit www.realstaffing.com