Annual Product Quality Review Pharmacy Resident (Pharmaceutical Industry Residency Program PIRP)

Job Responsibility: The Position Annual Product Quality Review P harmacy Resident (Pharmaceutical Industry Residency Program PIRP)

Division: Pharma

Department: Annual Product Quality Review (APQR)

Location: Mississauga Campus

Reports to: Functional/Senior Functional Manager

Position Purpose

To gain insight and experience working in Annual Product Quality Review. APQR is responsible for verifying the consistency of the existing process, the appropriateness of current specifications for both starting materials and finished product, to highlight any trends and to identify product and process improvements.

Pharmacy Residents are expected to perform their responsibilities. They are expected to work cross-functionally and help coordinate quality-related activities across the APQR ecosystem and with other internal partners.

Your Key Responsibilities

• Prepares a major research project on an identified issue or question of relevance to the Industry as a joint collaboration between the Company (Roche) and the University of Toronto.

• Conducts annual single-site, cross-site, and E2E reviews to deliver site and E2E APQR reports per requirements in GSP037.

• Supports the compilation of APQR reports via the acquisition and visualization of data from sites across the Roche network.

• Contributes to the performance metrics and overall Quality assessment and reporting as part of the APQR business process.

• Works with APQR stakeholders to identify, escalate, and resolve product quality issues.

• Proposes APQR actions items, as needed.

• Provides training and guidance as needed regarding the Global APQR process, including planning and implementation of procedures.

• Supports the development, maintenance, and execution of Global APQR systems, projects, and administrative activities.

• Performs any other tasks as assigned to support APQR and Quality oversight activities (e.g., process governance, systems/tools, operations maintenance, training matrices and materials, document and records management, procurement, etc.).

• Works independently to actively contribute to the success of the Global APQR team objectives and OKRs. Ensure cross-functional team deliverables are completed in a compliant, accurate, high quality and timely manner.

Who You Are

• You hold a Degree in Pharmacy (Bachelor of Pharmacy or PharmD).

• The Industrial Pharmaceutical Industry Residency Program (PIRP) is managed by the Leslie Dan Faculty of Pharmacy, University of Toronto and is geared to those who are part of this program.

• Experience collaborating in a global setting to support product teams and global quality initiatives is a plus.

• Technical expertise in small and large molecule drug substance and drug product manufacturing processes and associated control and documentation systems. Knowledge of medical devices and device combination products is desirable.

• Experience with enterprise databases, collaboration platform tools, and analytics (IT platforms) is preferred.

• Experience in routine (business and/or compliance) metrics reporting processes is desirable.

• Experience with technical writing is a plus.

• Demonstrates strong knowledge of Global pharmaceutical/biotechnology industry regulations, and GMPs as well as Roche standards and guidance documents. This includes the ability to interpret standards for implementation and review.

• Demonstrates experience in Quality and pharmaceutical or biopharmaceutical manufacturing.

• Demonstrates strong knowledge of analytical data, critical thinking skills, proficiency in the application of statistics and technology platforms.

• Demonstrates excellence in communication. Must communicate clearly and professionally both in writing and verbally, including effective facilitation skills. Fluent in English.

• Ability to lead cross-functional teams to resolve complex technical, quality, and business process-related issues; extract optimized business results through skillful collaboration and application of principles for influencing without formal authority.

• Proactive in building relationships and working with global interdisciplinary teams in collaborative cross-functional settings.

• Drives continuous improvement and operates with a Lean and Agile mindset.

• Demonstrates resourcefulness, proactive dynamic learning potential, matrix leadership, and accountability.

• Mentors network stakeholders and Global APQR stakeholders on process governance, executions and business operations systems.

• An additional language proficiency to support Roche network regional collaboration preferred (especially German).

The statements made in this are intended to describe the general nature and level of work being performed by those persons assigned to this job. These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of people assigned to this job.

This position is not eligible for relocation support.

Who we are

At 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 Roche's truly innovative culture.

As of January 4, 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.