GMP Compliance Specialist

vor 2 Wochen

Basel, Basel-Stadt, Schweiz Roche Vollzeit
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

In this role as GMP Compliance Specialist, you will work in "Synthetic Molecules Technical Development" (PTDC). PTDC brings a broad range of experience across drug substance (DS), drug product (DP), and analytical sciences. We collaborate closely with key partners in research and early development, as well as our commercial counterparts. PTDC is responsible for the technical development of our synthetic molecule pipeline and for manufacturing drug substances and products for clinical studies.

As a GMP Compliance Specialist in the GMP Support & Compliance team of Operations Support & Compliance (PTDC-T), you are a key contact and partner who provides expertise and support in GMP compliance in IMP manufacturing and technical development. This role is key to enabling smooth operations for Synthetic Molecules Technical Development and aligns business requirements with several partners and stakeholders.

Your key contribution is:

- Owning and facilitating GMP compliance processes for PTDC in close collaboration with the global PQS network.

- Participate in global PQS document lifecycle processes and actively influence authoring communities. Manage and track local impact assessments and implementation of current PQS requirements.

- Being an expert and first-level support for quality systems and their respective business processes (e.g., Cornerstone, Veeva OneQMS, QualityDocs, QRM, CIDM)

- Driving optimization and standardization of GMP-related processes and the existing document landscape in close alignment with key stakeholders

- Collaborating with team members in a role-based working environment, as well as building and growing relationships with customers and partners across functional boundaries

Your Profile:

- You have a Master or equivalent and/or higher degree in chemistry, pharmaceutical sciences, and/or exceptional experience in a GMP environment within the pharmaceutical industry.

- Experience in synthetic molecule manufacturing and/or quality control is a plus.

- You are fluent in German and English and enjoy collaborating with diverse international teams.

- You like working flexibly in an experienced team and appreciate carrying out diverse and varied activities.

- You appreciate being empowered to make decisions in your field of expertise and actively seek feedback from others.

Location: Basel

Roche is strongly committed to a diverse and inclusive workplace. We strive to build teams that represent a range of backgrounds, perspectives, and skills. Embracing diversity enables us to create a great place to work and to innovate for patients.

Are you ready to apply? We want someone who thinks beyond the job offered - someone who knows that this position can be an outstanding opportunity to craft the future of Roche.

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.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more.

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.

Roche is an Equal Opportunity Employer.

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