Caprion Biosciences, a contract research organisation with facilities in Montreal (Canada), Gosselies (Belgium) and Freemont (USA), offers analytical services to biopharmaceutical companies for the characterization of the human immune response in pre-clinical and clinical samples.
Caprion operates globally, with partners in North America, Europe and Asia, including large pharmaceutical companies and biotechs.
In the context of its growing immune monitoring service offering, Caprion is looking to hire a Compliance Specialist, for its site in Gosselies, Belgium.
Reporting to the Director of Scientific Operations, the Compliance Specialist (a) monitors and regularly verifies study data to ensure compliance to Caprion SOPs, (b) implements, manages, and maintains procedures for the verification of study data and reports, (c) works closely with Operations and QA to ensure scientific team members and analysts are aware of, and adhere to process updates, (d) provides compliance expertise and guidance to analysts and study directors to ensure the Global Compliance organizational processes are fully optimized.
Tasks include :
- Work independently to monitor and regularly verify study data to ensure compliance to Quality requirements, and ensure corrections are made appropriately according to Caprion SOPs through data review and in-life audits.
- Liaise with Operations and QA to identify root cause and resolve anomalies, using existing solutions or creating new ones.
- Implement, manage and maintain procedures for the verification of study data and reports, including periodic data verifications and review to ensure report accuracy.
- Train staff on procedures and processes to ensure compliance.
- Implement procedures in partnership with Operations and QA to streamline and improve documentation/QC process.
- Use best practices and knowledge to identify opportunities to improve business processes and performance, and advise Operations possible technical solutions.
- Act as a resource and trainer.
Profile of the applicant :
The applicant must hold a bachelor or master degree (or the equivalent) in a life science discipline such as biology, medical biology or biochemistry/biotechnology. The applicant must have a minimum of 5 years working in a GLP environment or in an equivalent Quality System. Auditing experience is an asset.
The applicant must :
- Have a thorough knowledge of GLP-GDP regulations;
- Demonstrate excellent oral and written communication skills;
- Demonstrate excellent organization skills and ability to multi-task to meet deadlines in a fast-paced, changing environment;
- Be able to work independently, autonomously and as part of a team;
- Be detailed and process-oriented, meticulous and show commitment to achieve good quality work.
- Be functional in French and English (spoken and written).
- Full time permanent contract, with possibility of rapid start.
- A professional, dynamic and stimulating work environment.
- A competitive salary package including benefits, adapted to your experience and the context.