We are looking for a QA Coordinator to reinforce the CluePoints Quality Assurance Team. As QA Coordinator, you will closely work with all CluePoints departments to ensure the quality and completeness of the CluePoints' Quality Management System, provide input in validation and qualification activities and participate in audit organization.
Please note that this is not a Software QA Tester position.
TASKS AND RESPONSIBILITIES
- Define QA strategy and participate in quality improvement activities.
- Ensure the maintenance and development of the CluePoints' Quality Management System.
- Ensure correct implementation of CluePoints Policies and Procedures (Change Management, Incident Management, Access Management, Deviation Management, Risk Management, etc).
- Participate to newcomer's orientation and to the maintenance of the training records for all employees.
- Participate in the preparation, hosting and follow up of audits (client audits, provider audits, internal audits).
- Participate in the execution of the validation planning of the CluePoints developed applications and in the development and review of CSV documentation.
- Ensure the implementation of Good Documentation Practice.
SKILLS AND COMPETENCES
- Fluent in English.
- Good working knowledge of Microsoft Word and Excel.
- Training skills including presentation experience is preferred.
- Strong interest in IT environment and conversant with MS Office applications.
- Knowledge of Veeva Quality Docs is an asset.
- Knowledge of Quality Management System.
- Good interpersonal skills (communication, organizational and time management skills).
- Report quickly and accurately (oral and written).
- Ability to work independently.
- Communicative, assertive, diplomatic and strive for a win-win situation.
- Ability to solve problems and to motivate others.
- Able to utilize pragmatic approach and have an eye for detail.
- Analytical, set priorities quickly, and have the sense of planning and organization.
EXPERIENCE
- Between of 1-5 year experience with in a pharmaceutical or regulated environment.
- Experience in the clinical research environment.
- Experience with GCP in a pharmaceutical company, with Risk Management practices, Corrective and Preventative Actions, Quality Management System, CSV, and regulatory requirements such as FDA, EMA, ISO 9001.
- Experience in Computer System Validation, GAMP, CFR 21, Part 11 is an asset.
- Experience with SOC 2 is an asset.
EDUCATION
- Bachelor or Master in a health related field, Engineering or equivalent experience.