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
Quality and Technical Guidance
- Ensure the project is performed according to the Roche Standards and Good Practices, ensure the site validation program complies with all regulatory and Roche corporate requirement, and Good Practices,
- Review and approve site Validation Master Plan (VMP)/project plans and ensure the strategy meets business and regulatory requirements. As needed, review/approve validation protocols, engineering change orders, Standard Operation Procedures (SOP), engineering commissioning and turnover packages.
- Responsible for the project CSV, Data Integrity, C&Q strategy execution in Roche compliant to Annex 1, GAMP 5 and applicable regulations in Dragon project phase in collaboration with Project, F&E, MSAT, Manufacturing and C&Q team,
- Oversee as Quality the Strategy and Execution of C&Q, and represent Quality Assurance in design reviews, construction, and qualification activities. Review commissioning and qualification documentation, including URS, IQ, OQ, and PQ protocols/report.
- Support the development and implementation of C&Q and validation plans aligned with project timelines.
- Participate in risk assessments to define qualification/validation requirements. Perform QA reviews of system impact assessments and equipment categorization.
- Act as the QA point of contact for discrepancy, deviation, CAPAs, and change controls related to C&Q activities.
- Provide recommendations for process improvements in C&Q and validation activities.
- Collaborate with project, F&E, MSAT, manufacturing, and QC teams to address quality issues.
Qualification and Experience 能力与经验
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.
Leadership Competencies
- Models Integrity
- Focus on value and customer
- Align for success
- Deliver results
- Learn for the future
Job Required Competencies
- A minimum experience of 7 years in pharmaceutical or biotechnology in QA or QV, ideally in a multinational company.
- Aseptic Filling experience is required and experience in the new DP facility startup readiness is expected.
- In depth knowledge of current GMP standards and guidelines related to equipment, utilities and facilities commissioning and qualification (e.g. ISO, EN, ICH, FDA, ISPE).
- Strong understanding of risk-based approaches to commissioning and qualification/validation. Hand-on experience with qualification/validation lifecycle (URS, FAT, SAT, IQ, OQ, PQ, and cleaning/process validation.
- Able to logically solve problems in order to find timely solutions.
- An ability to interact and communicate with all types of personalities in an effective and diplomatic manner
- Fluent communications skills in English and the ability to effectively communicate, collaborate, and foster positive interactions with team members and stakeholders.
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.