GCP Consultant GCP Auditor
GCP Consultant GCP Auditor
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Job Description
Independently oversee and manage multiple audit programs while maintaining compliance with applicable processes and procedures
- Successful Leadership and oversight of external contractors with a dedication for building strong relationships
- Demonstrates Excellence in Project Management through the successful provision of quality deliverables; generation and maintenance of project governing documentation and plans; oversight of key performance indicators (KPIs) and Key Quality Indicators (KQIs); while maintaining compliance with contract requirements and financial agreements.
- Resource and maintain the audit programs and schedules
Planning preparation conduct reporting and follow up of various types of GCP audits according to expected quality and timelines
Executing audits based on a comprehensive understanding of all regulatory requirements and Good Clinical Practice (GCP).
Performing GCP quality assurance projects on behalf of client companies within the pharmaceutical/biotechnology industry.
Assisting with business development activities
Qualifications :
Experience in coordinating and managing inspection preparation activities for GCP process inspections both at the sponsor and investigator site. BSc in Life Science preferred
Experience in conducting and leading internal and external GCP audits for a variety of stakeholders
Experience in conducting a range of service provider audits (e.g. investigator site audits fullservice CRO phase I Mock Inspections)
Experience in conducting GCP systems audits.
Experience in conducting GCP mock inspections to Competent Authority standard considered a significant advantage.
Expert knowledge of national and international GCP legislation and guidelines
Up to 40 travel and ability to conduct remote audits
Additional Information :
Why ADAMAS
As an organization we prioritize diversity equity and inclusion by creating an equal opportunities workplace and a humancentric environment where people of all cultural backgrounds genders and ages can contribute and grow.
To succeed we must work together with a human first approach. Why Because our people are our greatest strength leading to our continued success on improving the lives of those around us.
We offer:
Training and career development opportunities internally
Strong emphasis on personal and professional growth
Friendly supportive working environment
Opportunity to work with colleagues based all over the world with English as the company language.
Our core values are key to how we operate and if you feel they resonate with you then ADAMAS an Ergomed Company is a great place to join!
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships
We look forward to welcoming your application.
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
