Quality Assurance Auditor - Toronto, Canada - Think Research

Think Research

Verified Company

Toronto, Canada

1 week ago

Posted by:

Sophia Lee

beBee Recruiter

Description

The Company
BioPharma Services Inc. is a subsidiary of Think Research.

BioPharma Services was founded by two surgeons dedicated to advancing medical science to improve the life and spirit of their patients.

With this same dedication and vision in mind, these physicians brought life to BioPharma.

Through each success, and even some failures, the perpetual drive to make BioPharma great has been determined by the will and dedication of our people.

The will to empower their colleagues, friends and teammates to excel in all facets of clinical research and inspire performance to achieve greatness.

It is with this same culture and brand of excellence that we welcome our clients.

To experience the team community that has propelled us into a global leader in medical research, to be a client-focused partner, where people and patients matter.

Again, we invite you to come and meet our people. Our people who have learned that success is better achieved and celebrated as a team than as an individual.

Why Us?

It's not every day that you have the chance to change the way your friends and family are cared for
Make an impact
Everything we do and we do it with passion is to improve the quality of life for patients who benefit from the clinical trials that we perform for global pharmaceutical companies.
We're growing, and so will you with leaders who will support your development through mentorship and other opportunities
Collaborative, creative, dynamic and flexible work environment, with a startup spirit

You Will Have The Opportunity To:

Perform audits of clinical trials for compliance with Good Clinical Practice (GCP),
Standard Operating Procedures (SOPs), study protocols, pertinent regulations and

- guidelines (FDA, Health Canada, MHRA, ANVISA etc.)

Audit clinical documentation that captures (1) before the clinical phase of the trial

- commences, (2) during the clinical conduct of the trial, and (3) after completion or
- termination of the trial, clinical databases and clinical study reports.

Conduct various corporate audits, including audits of equipment maintenance, training

- records and privacy.

Keep Management up to date with findings and follow up on corrective actions.
Assist QA management in the training of BPSI staff on SOPs and GCPs/GLP.
Coordinate and interact with other departments to ensure corporate, departmental and

- project goals are met.

Perform other relevant tasks delegated by QA management.

What You Will Bring:

University degree in a scientific area, or equivalent degree/experience.
12 years QA experience, preferably including audits of Phase 1 and/or BA/BE studies.
Excellent working knowledge of ICH guidelines, GCP, FDA regulations and guidelines,
HPFB guidelines, and Canadian Food and Drugs Act.
Experience writing and reviewing Standard Operating Procedures (SOPs).
Excellent organization, multitasking, communication and interpersonal skills.
Think Research and all subsidiaries are proud to be an equal opportunity employer and is committed to creating a diverse and inclusive workplace, free of discrimination and harassment._
We provide equal employment opportunities (EEO) to all employees and applicants regardless of race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status._
We are committed to providing accommodations for people with disabilities. Should you require an accommodation, we would like to work with you to meet your needs._

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