A new role is available at The Clinical Trial Company (TCTC) for an experienced GCP Quality Assurance Auditor to join our Quality Assurance Team. TCTC is a full service CRO with headquarters in Montreal, QC and the United Kingdom. TCTC operates throughout North America, South America, Europe, India, China, Africa and Australia.
The QA Auditor will be responsible for conducting GCP external and internal audits based on TCTC’s audit program, or as required by a sponsor.
Essential duties and responsibilities include, but are not limited to the following:
- Schedule, prepare and conduct GCP audits of clinical investigator sites, vendors, databases, clinical laboratories, and CROs
- Ensure compliance to protocols, procedures and regulatory requirements
- Produce descriptive and detailed audit reports
- Categorize and classify audit observations
- Propose effective and efficient CAPA, where applicable
- Conduct CAPA follow ups, where applicable
- Perform trend analysis
- Liaise with TCTC departmental heads to support implementation of business improvement initiatives
Knowledge and Specialized Skills:
- Good working knowledge of technical concepts required for GCP auditing
- Knowledge of pharmaceutical/biotechnology process and auditing standards
- Sound knowledge of GCP regulations and guidelines, as well as GLP and GCLP
- Ability to interpret and apply regulatory requirements
- Excellent oral, written and interpersonal communication skills required
- Ability to effectively communicate and successfully manage conflict
- Able to travel
Please forward cover letter and CV.