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8 Ahatha Infra Management Jobs
GXP CONSULTANT & AUDITOR
Ahatha Infra Management
posted 26d ago
Job Role Insights
Key skills for the job
Job Description
- Manages QAS projects for the delivery of QA GxP services to Clients, in full compliance with the applicable GxP Legislation, Clients requirements and the Regulatory Business Quality Standards
Requirements
Accountabilities
- To Prepare and perform audits on behalf of clients, and relevant reporting to them
- To Assist clients in supporting their Annual Audit plan
- To Collaborate with the QA Director to manage the external Auditors and engage them as appropriate
- To Develop the workflow and operational planning for the QA GxP Services provided
- To Ensure that Quality & Projects Plans, are developed according to client requirements
- To Ensure oversight for day-to-day interactions with all staff involved in the services delivery
- To Develop standard operating procedures and work guidance and/or reviews Clients SOPs if applicable, to ensure full compliance
- To Contribute to GxP quality management plans and compliance program
- To Assist clients in audit/inspection readiness
- To Ensure tracking of compliance metrics
- To Assist clients in identifying and up following up on corrective action plans arising from audits and inspections
Soft / General / Technical Competencies required
- English, Very good/Fluent
- GxP regulations
- Auditing (and related qualification if required)
- Planning, organizing, controlling
Professional Background and Experience
- Bachelor's degree in life science disciplines
- At least 5 years of experience as a GxP
Employment Type: Full Time, Permanent
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