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GMP Expert in the GMP Support & Compliance section of Operations Support & Compliance (PTDC-T)

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Job description

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GMP Expert in the GMP Support & Compliance section of Operations Support & Compliance (PTDC-T)

As a GMP Expert, you will be working in the “Small Molecules Technical Development” organization within “Global Technical Development”.

Behind every presentation of each product sold by Roche is the involvement of Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes medicines at sites around the world and includes more than 10 000 employees worldwide.

"Global Technical Development" (PTD) actively collaborates and develops innovative technical solutions to efficiently transform scientific ideas into products. The mandate of the group is, to reliably deliver the pipeline and supply quality products to patients. The group excels in its work through innovation, collaboration, dedication, and mutual respect and makes valuable contributions every single day, continuously improving what it does.

“Small Molecules Technical Development” (PTDC) brings a broad range of experience across drug substance (DS), drug product (DP), analytical sciences and manufacturing S&T, and collaborates closely with key partners in the departments Research and Early Development (pRED / gRED), Small Molecules (PTC) and PTD. PTDC is responsible for late stage technical development of our small molecule pipeline, manufacture of DS and DP for clinical studies.

As a GMP Expert in the GMP Support & Compliance team of Operations Support & Compliance (PTDC-T) you serve as a key contact and partner to provide PTDC specific services and support in the area of GMP compliance. You are an expert for phase appropriate implementation of local and global requirements in the field of IMP manufacturing and analytics. This role is key to enabling smooth operations for colleagues in Small Molecules Technical Development and aligns business requirements with several partners and stakeholders.

As a GMP Expert in Operations Support & Compliance your key contribution is:

Ensuring compliance of Small Molecules Technical Development with Roche PQS and health authority requirements for IMP manufacturing and analytics

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

Collaborating with all the leaders and employees to build and grow relationships with all customers and partners across functional boundaries

Management and improvement of harmonized PTDC processes like training, archiving, quality risk management

Coordinate audits within PTDC and represent GMP related topics during health authority inspections and internal audits

Your Profile:

You have a Master or equivalent and/or higher degree in chemistry or pharmaceutical sciences and at least 5 years operational experience in a GMP environment within the pharmaceutical/biopharmaceutical business environment.

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

For this position you bring the following qualifications:

Strong technical background in GMP manufacturing or QC and solid understanding of health authority requirements and expectations

Collaboration and interpersonal skills with proven influencing and negotiation skills as well as excellent skills at building and maintaining constructive and effective relationships with team members as well as internal and external partners and stakeholders

Strong ability to make decisions, inspire, lead changes and assess risks

Good verbal and written communication skills in German and English

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Roche is an equal opportunity employer.
Quality, Quality > Quality Validation

·  Who we are

At Roche, 98,000 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.

Roche is an equal opportunity employer.

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