Audit Particulars Description/Requirements
Audit Type Re-qualification (GCP)
• Clinical Trial Management
• Biostatistics
• Data Management
• Medical Monitoring
Delivery On Site audit
Audit time breakdown:
Audit Preparation and document review 10 hours (Audit Preparation)
2 hours – Training on Roivant SOP
Audit Conduct 24 (3 day, 8 hrs./day)
Audit reporting 20 hrs.
Total audit hours 56 hours
We are seeking consultants who can provide support as a Quality Compliance Auditor (GCP and GCLP) in a pharmaceutical and biotechnology industry.
Responsibilities:
• Conduct and manage quality, compliance, and auditing activities to provide assurances that operational activities are conducted in compliance with applicable regulations, guidelines and the company’s policies and standards.
• Support contracted audits to verify compliance.
• SME to assist with facilitation of audits in preparations for and participate in regulatory authority inspections.
• Hosts external audits/inspections e.g. regulatory inspections, strategic clients. Assists with the facilitation of audit responses.
• Provide consultation and compliance advice for the organization and support a quality framework that protects patient safety and assures regulatory compliance.
• Interpretation of regulations and guidelines, searches of published information and interactions with other QA and regulatory professionals.
• Support compliance projects such as management of quality issues, CAPA projects, or other Quality Assurance and cross-functional initiatives.
• Delivery of training in performance of audits (basic, intermediate, complex).
Requirements:
• A minimum of a Bachelor’s Degree in a Pharmacy, Chemistry or Biology related discipline.
• Postgraduate degree (MSC or equivalent) in science or management related discipline, preferable.
• 10 years industry experience on a regulated environment
• With lead auditor certification is preferred
• Experience of industry quality systems/standards.
• Extensive knowledge of GCP and GLP requirements is a MUST
• Experience on CAP and CLIA is a MUST
• Expanded Laboratory Management Solutions (ELMS) knowledge is preferred
• Experience on PBMC (Peripheral blood mononuclear cell) is preferred
• Knowledge on toxicology is preferred
• Excellent interpersonal/organizational skills, e.g. communication, decision making, negotiating, problem solving.
• Able to influence QA strategy systems/standards and ability to apply appropriate regulatory knowledge to multiple scenarios.
GCP Audit-On Site NJ- (232698)
