Perform audits on studies, facilities, processes and validation activities and report all findings to Citoxlab | A Charles River Company (Citoxlab) management. Inform Citoxlab management of deficiencies and areas of operations that need improvement.
MAJOR ELEMENTS OF RESPONSIBILITIES
- Perform critical phase, process and facility audits;
- Perform thorough audits in compliance with applicable Standard Operating Procedures (SOPs), study plans, Good Laboratory Practice (GLP) regulations and guidance documents;
- Communicate and report audit findings in a timely manner to the responsible personnel;
- Work closely with scientific staff and Operations to achieve GLP compliance;
- Ensure GLP regulations and guidance, as well as Citoxlab SOPs are followed;
- Understand and consistently apply SOPs;
- Maintain good verbal and written communication with Operations;
- Inform QA management of deficiencies and suggest improvement;
- Meet and adhere to set deadlines;
- Remain informed on all legislation and developments related to job through self-education and external training;
- Assist in training of staff;
- Substitute and/or assist department colleagues;
- Perform any other reasonable tasks that may be required.
- Work performed in an office environment;
- Considerable sensory attention is required on a regular basis;
- Often requires concentration to work in front of a computer;
- Work with deadlines.
- University degree or pertinent experience in the domain;
- Minimum of 1 year of experience as Quality Assurance Auditor in a GLP regulated environment or equivalent;
- Strong knowledge of related legislation, principles, practices and procedures;
- Good knowledge and application of GLP;
- Oral and written English required. French is a definite asset;
- Strong organizational, interpersonal and communication skills;
- Strong problem-solving and analytical skills;
- Ability to work under time constraints and adapt to change;
- Meticulous attention to detail;
- Good practical knowledge of auditing computerized systems validation for compliance is a definite asset;
- Working knowledge of related computer applications; Fast typing ability is an asset.