Gcp Auditor - Toronto, Canada - Adamas Consulting
Description
Company DescriptionADAMAS is a well-established, leading provider of mission-critical regulatory compliance and consulting services to the global pharmaceutical industry.
It operates across Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Computer Systems Compliance (CSC) (together, GxP).
Founded in 2007, ADAMAS has focused on ensuring that the highest standards of best practice are attained across the pharmaceutical sector.
We work with over 100 currently active clients and have worked with over 700 pharmaceutical companies, including 40 of the 50 largest global pharma and biotech companies.
At ADAMAS, our people are our primary asset.We possess the highest and broadest level of in-house knowledge and can deliver genuine expertise and experience globally via in-house resources.
ADAMAS's success is down to the calibre of its people - to reward them we offer a competitive salary with benefits, excellent working conditions and a fulfilling and rewarding career, with plenty of opportunities for further development.
Job Description:
Responsibilities:
- 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:
Requirements:
- 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., fullservice CRO, biostatistics, data management, phase I)
- Experience in conducting GCP systems audits.
- Experience in coordinating and managing inspection preparation activities for GCP process inspections both at the sponsor and investigator site.
- 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
- Clinical Investigator Site Audit experience preferred
Why ADAMAS?
As an organization, we prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.
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.
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships
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