GMP Compliance Specialist

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Na Roche, você pode-se apresentar como você mesmo, abraçado pelas qualidades únicas que traz. Nossa cultura incentiva a expressão pessoal, o diálogo aberto e as conexões genuínas, onde você é valorizado e respeitado por quem você é, e permitindo que você prospere tanto pessoal como profissionalmente. É assim que pretend emos prevenir, deter e curar doenças e garantir que todos tenham acesso aos cuidados de saúde hoje e nas gerações futuras.

Junte-se à Roche, onde cada voz é importante.### A posiçãoAs a GMP Compliance Specialist in the GMP Support & Compliance team of Operations Support & Compliance (PTDC-T), you serve as a key contact and partner to analytical development unit PTDA, providing expertise and support for GMP compliance in analytical development and QC processes. This role is crucial in enabling smooth operations for PTDA and aligning business requirements with those of several partners and  this role, 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. ### The Opportunity In his role you will be responsible for:
* Managing, coordinating and facilitating local GMP compliance processes as quality risk management, deviations, CAPA and changes.
* Acting as an expert and first-level support for quality systems and their business processes  (e.g., Cornerstone, Veeva OneQMS, Quality Docs, QRM) incl. training of SME’s
* Management of access to GMP relevant areas and account management for GMP systems
* Inspection management for internal audits and health authority inspections within PTD
* 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### Who you are
* You have a Bachelor’s degree or higher (or equivalent) in Chemistry, Pharmaceutical Sciences, or solid operational experience in a GMP environment within the pharmaceutical industry
* You bring experience in synthetic and/or large molecule manufacturing and quality control (a strong advantage)
* You enjoy working flexibly in an experienced team and thrive in a collaborative environment
* You are curious about the team’s priorities and workload, and proactively offer support where needed
* You are empowered to make decisions in your area of expertise and take ownership of your work
* You actively seek feedback and use it to learn, grow, and continuously improve
* You have excellent language skills, fluent in German with good written and verbal communication in English### Quem nós somos

Um futuro mais saudável nos leva a inovar. Juntos, mais de 100 mil funcionários em todo o mundo se dedicam ao avanço da ciência, garantindo que todos tenham acesso à saúde hoje e nas próximas gerações. Nossos esforços resultam em mais de 26 milhões de pessoas tratadas com nossos medicamentos e mais de 30 bilhões de testes realizados usando nossos produtos de diagnóstico.

Nós nos capacitamos para explorar novas possibilidades, promover a criatividade e manter as nossas ambições altas, para fornecer soluções de saúde que mudem a vida e causem um impacto global.

Vamos construir juntos um futuro mais saudável.
** A Roche é um empregador que pratica políticas de igualdade de oportunidades.*
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