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About Roche
Roche fosters diversity, equity, and inclusion by representing the communities it serves. With a global presence in healthcare, diversity is an essential component of success. Inclusion enables understanding of varied healthcare needs, leading to exceptional care. At Roche, every voice matters.
The Position
In this role as GMP Compliance Specialist, you will work in Synthetic Molecules Technical Development (PTDC), which brings experience across drug substance, drug product, and analytical sciences. PTDC collaborates closely with research and commercial counterparts, responsible for technical development of synthetic molecules and manufacturing drug substances and products for clinical studies.
As a GMP Compliance Specialist, you are a key contact and partner who provides expertise and support in GMP compliance for IMP manufacturing and technical development. This role is crucial for smooth operations in Synthetic Molecules Technical Development, aligning business requirements with several partners and stakeholders.
Your Key Contribution:
- Owning and facilitating GMP compliance processes for PTDC in collaboration with the global PQS network.
- Participating in global PQS document lifecycle processes and influencing authoring communities. Managing and tracking local impact assessments and implementation of current PQS requirements.
- Being an expert and first-level support for quality systems and their respective business processes.
- Driving optimization and standardization of GMP-related processes and the existing document landscape in alignment with key stakeholders.
- Collaborating with team members and building relationships with customers and partners across functional boundaries.
Your Profile:
- You have a Master's degree or equivalent in chemistry, pharmaceutical sciences, or exceptional experience in a GMP environment within the pharmaceutical industry.
- Experience in synthetic molecule manufacturing and/or quality control is advantageous.
- You are fluent in German and English, enjoying collaboration with diverse international teams.
- You prefer working flexibly in an experienced team and appreciate carrying out diverse activities.
- You appreciate being empowered to make decisions in your field of expertise and actively seek feedback from others.
