GVP Compliance Manager
22 ore fa
About Arithmostech
We are experts in the Life Sciences industry & Technology.
As a trusted partner for technology and expert service provider across Clinical, Regulatory, Quality, Pharmacovigilance and Medical Affairs domains, we help companies achieve excellence in business operations.
Purpose of the Role
The GVP Compliance Manager will manage QAS projects for the delivery of QA GVP services to Clients, ensuring full compliance with applicable GVP Legislation, Client's requirements, and Regulatory Business Quality Standards.
Main Responsibilities
- Prepare and perform audits on behalf of clients, and provide relevant reporting.
- Assist clients in supporting their Annual Audit plan.
- Collaborate with the QA Director to manage external Auditors and engage them as necessary.
- Develop the workflow and operational planning for QA GVP Services provided.
- E nsure Quality & Projects Plans are developed according to client requirements.
- Oversight of day-to-day interactions with all staff involved in services delivery.
- Develop standard operating procedures and work guidance, and/or review Client's SOPs if applicable, to ensure full compliance.
- Contribute to GVP quality management plans and compliance program.
- Assist clients in audit/inspection readiness.
- E nsure tracking of compliance metrics.
- Assist clients in identifying and following up on corrective action plans arising from audits and inspections.
Requirements
To be successful in this role, you will have:
- Bachelor's degree in life science disciplines.
- At least 5 years of experience as a GVP QA Consultant and Auditor.
- English language proficiency (Very good/Fluent).
- GVP regulations knowledge.
- Auditing skills and related qualification if required.
Salary Range: $80,000 - $110,000 per year, depending on location and experience.
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