Pharmaceutical Quality GLP Auditor – Consulting

This is a fully remote position, open to applicants in Canada.

📋 Description

• Perform audits in accordance with Good Laboratory Practice (GLP), which includes planning, preparing agendas, conducting physical or remote audits, and writing reports.

• Assess compliance or qualification of CROs, Central Labs, and vendors.

• Create detailed audit reports that outline findings and identify root causes.

• Deliver written audit reports in English.

• Offer support for corrective actions and present results to QA leadership and stakeholders as needed.

• Collaborate with clients to uphold quality standards.

• Become a part of Advarra’s consultant network for projects based in Canada.

⛳️ Requirements

• At least 10 years of experience in Quality Assurance and/or Good Laboratory Practice (GLP).

• A minimum of 5 years of experience specifically in Good Laboratory Practice (GLP) auditing.

• Proven experience with the expectations of regulatory agencies (e.g., FDA, EMA) and activities related to audit readiness.

• Demonstrated ability to develop and implement quality assurance plans, audit programs, and corrective action plans.

• Proficient in English communication at a B2 level, both verbal and written.

• A Bachelor's degree is required.

• Strong skills in interpersonal communication and client interactions.

• Exceptional analytical, problem-solving, communication, and report-writing capabilities.

• Ability to work collaboratively across various departments and engage with both internal and external stakeholders.

• Candidates must reside in Canada.

• Candidates who are not already part of the Advarra network must register using the Expert Enrollment Form.

🏝️ Benefits

• A welcoming and collaborative work environment.

• Opportunities within the consultant network.

• The chance to contribute to clinical research and improve patient health.

• Reasonable accommodations are available for applicants with disabilities.