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The Position

QA Specialist (Senior)

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.

That’s what makes us Roche.

As a QA Specialist, you play a key role in leading initiatives for the maintenance and continuous improvement of the Quality Systems, ensuring Quality and Regulatory Compliance across RSTO. You will also lead execution and ongoing monitoring of Quality System elements, including Pharmaceutical Quality System (PQS), Annual Product Quality Review (APQR), Quality System Management Review (QSMR), Quality metrics and Quality Risk Management.

Your Opportunities

• Implement Quality Risk Management and provide relevant tools and expertise. Facilitate Risk assessments, in coordination with site risk management processes.

• Ensure potential product and patient risks are systematically assessed, controlled, reviewed and communicated, and risk management activities are documented appropriately.

• Ensure escalation of product quality risks to senior management in a timely manner and ensure documentation and approval of APQR for each of the products manufactured at RSTO meet end to end APQR timelines.

• Coordinate and communicate with different functional groups and department both on site and global to consolidate individual data summaries for APQR process.

• Collect and provide on time the executive summary reports as required by the GSP and the corporate APQR team.

• Coordinate efficient implementation of new and revised PQS documents for the site and ensure maintenance and continuous improvement of Pharma Quality Systems processes.

• Facilitate Quality System Management Review at the site level and support site requirements for quality system metrics reporting and data analysis.

• Create all the necessary reports I metrics I KPI's required by the Site and Global network and support the Quality Council and ensure meetings scheduled and minutes are completed timely.

Who you are

• Possess Bachelor’s Degree (Science or technical field such as pharmacy, life science, biology, chemistry or engineering is preferred) with at least 5 years of relevant working experience in a biotech or pharmaceutical operating environment is preferred

• Able to demonstrate strong stakeholder management, independent problem-solving and critical thinking abilities

• Strong knowledge in of Quality System principles, practices and standards for the pharmaceutical industry

• Good knowledge of cGMP relevant to the pharmaceutical industry and Risk Management

• Able to interpret and relate Quality Standards for implementation and review

• Possess customer focused mindset, curiosity, courage in experimentation and has strong influencing ability and able to effectively build trust and relationships

• Take responsibility, demonstrate leadership, drive results and achieve expected outcomes

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 is an Equal Opportunity Employer.