Specialist, QS

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Principle Roles & Responsibilities / Accountabilities主要职责/责任
Quality and Technical Guidance

• Works with the management team to support the development and oversight of robust quality systems, including both implementation and operation at site level
• Supports the site level Quality Management Review (QMR) program including monitoring and reporting key performance indicators, as appropriate
• Review systems and analyze data (paper or electronic) to identify specific compliance and data consistency issues
• Implements and executes the Inspection Readiness program; including Roche Corporate Inspections and Health Authority Inspections, which includes site inspection preparation, program management, response and commitment process
• Facilitates training on all GMP & Quality Compliance programs
• Support the continuous improvement and oversight of Quality System Compliance programs and identifies and implements new technologies to improve the compliance and efficiency of QS operations
• Collaborate with project, F&E, MSAT, manufacturing, and QC teams to address quality issues
• Other related duties as assigned

Education/Qualifications

• The candidate should have at least a Degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, or a related discipline
• Certification and training such as auditor training will be advantageous

Job Required Competencies

• A minimum experience of 2 years in pharmaceutical or biotechnology in quality assurance,including Data Integrity (ALCOA+) compliance, self-inspections, ideally in a multinational company
• Experience supporting cGMP manufacturing operations through administration and enforcement of the Quality Management System
• Ability to apply a phase appropriate, risk-based approach to QA operational decisions
• Aseptic Filling experience is required and experience in the new DP facility project is expected
• FDA/EU cGMP know-how and understanding of ICH guidelines, with exposure to the international regulatory network is preferred
• Able to logically solve problems in order to find timely solutions
• Ability to work well independently and within a team
• Strong follow-up and organizational skills
• Fluent oral and written communication skills in English with technical writing experience required
• Project management skills are preferred

Who we are

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

Roche is an Equal Opportunity Employer.