Senior Specialist, QV Biologics 生物制药质量验证高级专员

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

●           Oversee qualification & validation activities according to the Roche Standards and Good Practices, ensure the site validation program complies with all regulatory and Roche corporate requirement, and Good Practices,

●           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,

●           Acts as subject matter expert in projects for qualification related issues, under direction of a project manager or Head of Quality.

●           Drafts/Reviews Validation/Qualification Project Plans and Validation/Qualification Project Reports.

●           Writes/Reviews protocols and summary reports and performs qualification activities on the basis of the protocols (or have them being written and / or performed by others).

●           Assesses independently whether equipment / systems should be qualified and reviews this with QA.

●           Assesses by others within ES or by external companies established qualification documents and let these documents may change according to his insights.

●           Supervises and controls validation activities carried out by third parties.

●           Assesses validation packages established by suppliers.

●           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.

●           Collaborate with project, F&E, MSAT, manufacturing, and QC teams to address quality issues.

Supports lean initiatives in the area of qualification and validation.

Education/Qualifications

●           Msc or experienced BSc degree in (Bio) chemical Engineering, Biochemistry, Applied Science.

●           Certification and training such as auditor training will be advantageous.

Job Required Competencies

●           A minimum experience of 3 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.

●           Sound knowledge of current GMP standards and guidelines related to equipment, utilities and facilities commissioning and qualification (e.g. ISO, EN, ICH, FDA, ISPE), with experience in aseptic filling experience and qualification/validation (URS, FAT, SAT, IQ, OQ, PQ) for new DP facilities startup 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.