Quality Specialist - Jobs in Mississauga, ON

Job Description

The PositionQuality Specialist is responsible to support the Local Quality Responsible (LQR) to proactively ensuring that all GCP /GVP governed activities are delivered to the Roche standard of quality and drives compliance in accordance with the applicable regulatory requirements, the Roche QMS, Policies and written procedures and industry best practices. The Quality Specialist supports LQR in establishing, maintaining and fostering relationships with key business partners across the affiliate so that the global expectations for quality management are met by providing efficient, effective and value added support across the local organization.Key Accountabilities:

• Supports LQR in managing the strategic and operational performance of the Quality Management System (QMS) at affiliate level, ensuring the successful delivery of the Global Quality Strategy, in alignment with annual Quality Objectives, whilst maintaining oversight and adherence to local regulatory requirements.
• Promotes a quality culture that ensures the highest standards of Quality and Medical Compliance.
• Proactively monitors and oversees external regulatory changes affecting affiliate quality and compliance.
• Works in partnership with key affiliate stakeholders to maintain quality standards and to support continuous improvement in the Affiliate.
• Supports LQR in driving and enabling the overall CAPA Management process at local level.
• Ensures the implementation of global processes and process improvement initiatives in affiliate with the necessary local subject matter experts in collaboration with the LQR.

Strategy and Governance:

• Understand and support the LQR in 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.
• Support LQR in monitoring the annual GCP/GVP local Quality Plan objectives that are aligned with Global Quality objectives.
• Support LQR in collecting and compiling data for affiliate level Quality Report to summarize key data for senior leadership to take informed decisions.
• Assist LQR in coordination of the Affiliate audit and inspection process at the local level. Ensure close collaboration with the PDQ Inspections Group regarding any upcoming inspections

Organizational Effectiveness:

• Support LQR in liaising with departments to assess job role training requirements at a local and global level.
• Support LQR in ensuring that a local training grid is in place for all GCP/GVP roles in the affiliates and that appropriate local training curricular are defined and followed in collaboration with local stakeholders.
• Support LQR in ensuring in a timely manner, that local GCP/GVP personnel are assigned to the appropriate global job families to receive global core compliance training.
• Support LQR in demonstrating oversight of GCP/GVP Training metrics and follow-up of training compliance where needed. Recommend proposals to LQR of mitigation and corrective actions.
• Support LQR in collection and maintenance of employee qualification documentation (e.g., CVs and JDs) when applicable.

Processes & Procedures:

• Support LQR in the local controlled document management process
• Support LQR in ensuring the consistent alignment between local and global procedural documents with local regulatory requirements and ensures effective implementation.
• Support LQR in ensuring that the local GCP/GVP Controlled Documents are uploaded and maintained in the Document Management System
• Records Management:
• Support LQR in ensuring the records management requirements for QMS are established and followed by Affiliate according to the Roche Global Records Management Directive in collaboration with the respective COREMAP representative.

Continuous Improvement:CAPA

• Assist LQR to ensure that deviations to GCP/GVP processes are managed in accordance with Roche global standards.
• Assist LQR to ensure that all applicable affiliate stakeholders are trained and know their responsibilities of the Global CAPA processes and their responsibilities as identifiers of potential deviations.
• Assist LQR to facilitate the root cause analysis and impact assessment.
• Assist LQR to ensure affiliate CAPAs (from local self-identified deviations/affiliate audits and inspections) are documented, tracked, monitored and followed up to timely and effective closure.

Metrics

• Support LQR in implementation of improvements to quality metrics and identified gaps in collaboration with the business and QCCL.
• Assist LQR in performing trend analysis on data for discussion at LMCO & Affiliate management reviews with input from local SMEs (including LSR, Local DRA and APT).

Service Providers

• Support LQR to oversee the GCP/GVP service provider management process by liaising with key stakeholders to ensure that oversight plans are in place, performance of the vendor is regular monitored and accurate and regular risk assessments are completed & documented and actions taken where required.

Education / Skills / Knowledge / Experience Required

• Undergraduate degree from a recognized university (4 years)- Science based
• 3-5 years working experience in a biopharmaceutical company or equivalent
• 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.

Important: Relocation benefits are not available for this job posting.Who we areAt Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.Roche Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roches truly innovative culture.As of January 4, 2022, Roche requires all new employees who work in Canada to be fully vaccinated against COVID-19 on the date they take office. This requirement is a condition of employment at Roche that applies regardless of whether the position is on a Roche campus or remotely. If you have a valid reason for not being fully immunized, which is limited to certain specific medical reasons or other valid reasons protected by applicable human rights laws, you may request an exemption and / or adaptation measures regarding this vaccination requirement.Roche is an Equal Opportunity Employer.Quick Apply

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