Title: Quality Specialist
Division: Medical & Regulatory Affairs
The Quality Specialist is responsible for ensuring the maintenance of the Affiliate Quality Management System (QMS) and its related documents, in alliance with the Quality principles outlined in the Global Roche GCP /GVP Quality Manual.
Quality Management System (QMS)
- Understand and support the LQR in implementing the GCP/GVP QMS requirements for the business and monitor progress
- Monitor and follow-up on the progress of the Affiliate Quality Plan objectives.
- Work with departments to collect and compile data for quarterly reports for global and Affiliate Management Review
- Ensure that all Affiliate process documents that describe the QMS are properly maintained
- Ensure that all Affiliate processes are aligned with global Roche SOPs and local regulatory requirements
- Liaise with departments to assess job role training requirements at a local and global level
- Ensure local training grids are aligned with global and local needs
- Ensure training is appropriately assigned to the specific job function
- Reviews training metrics and provide analysis of training detected issues. Recommend proposals to LQR of mitigation and corrective actions
Deviation and CAPA Management
- Assist in the maintenance of the deviation and CAPA processes: i.e. tracking of responses and verification of CAPA commitment implementation.
- Maintain awareness of the global, cross functional process landscape
- Support LQR in liaising with Functions to ensure compliant Vendor Management processes are in place to ensure adequate vendor oversight
Inspection Readiness and supporting sponsor inspections
- Maintain awareness of local regulatory body requirements and inspection methods
- Ensure close collaboration with the PDQ Inspections Group regarding any upcoming inspection
- Assists in the facilitation of GCP/GVP regulatory inspections including preparation and coordination.
QMS Records Compliance
- Ensure the records management requirements for QMS are established and followed by Affiliate
- Ensure this is done in compliance with the Roche Global Records Management Directive, in collaboration with the respective CoreMap Records Co-ordinator
- Work with key stakeholders to facilitate compliance with required standards
- Perform quality assessments for GCP/GVP relevant areas across the affiliate organization to help identify quality and compliance areas of improvement
- Report quality and compliance related trends appropriately
- Provide support for quality systems improvement initiatives
- Undergraduate degree from a recognized university (4 years)- Science based
- General working knowledge of the Canadian Pharma industry and how it is regulated.
- Ideally, experience in Inspection Management with a robust regulatory organization, such as Health Canada
- Ideally, experience in conducting internal compliance assessments
- Project Management skills
- Good Communication and team player skills.
- Knowledge and experience in Good Clinical Practices (GCP) and Good Pharmacovigilance practices (GVP) as required in running clinical trials and working in a drug safety department, and auditing practices.
Qualified candidates are encouraged to submit cover letter and resume no later than Dec 10, 2019.
This position is not eligible for relocation support.
This position is open to applicants legally authorized to work in Canada.
NOTE: All employment is conditional upon the completing and obtaining a satisfactory background check, including educational, employment, references and criminal records (for which a pardon has not been granted) checks.
Roche is an equal opportunity employer and prohibits unlawful discrimination based upon any legally protected ground. Roche will make a good faith effort to accommodate the individual needs of applicants with disabilities in our recruitment process