Quality Control Project Lead — Roche

NewCHF 85'500 - 129'500
Roche · Basel (BS)
Categoria: Qualità Contratto: full-time Salario: CHF 85'500 - 129'500
Apply now
Location
Basel
Contract
full-time
Posted
Yesterday
SalaryCHF 85'500 - 129'500

Role overview

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.

Application process

  • Are you ready to apply? Who we are A healthier future drives us to innovate.

Company and context

  • Our department is responsible for testing direct materials, Active Pharmaceutical Ingredients (APIs), and drug products, conducted both internally and externally at Contract Manufacturing Organizations (CMOs).
  • Our team of skilled associates and scientists manages critical analytical tasks, including stability studies, validations, and method transfers. The Opportunity
  • Project Management: Lead and oversee analytical projects, ensuring strict adherence to GMP regulations, timelines, and quality standards.
  • Stability Study Coordination: Coordinate comprehensive internal and external (CMO) stability studies for synthetic molecules, APIs, and drug products.
  • Analytical Oversight: Ensure all testing is conducted according to regulatory guidelines, maintaining the highest standards of data integrity.
  • Data Review and Reporting: Review analytical data for precision, accuracy, and completeness.
  • Vendor Management: Collaborate with CMOs to ensure efficient communication, project execution, and compliance for all stability studies.
  • GMP Compliance: Ensure all stability activities strictly adhere to internal SOPs, GMP standards, and relevant regulatory requirements.
  • Problem-Solving: Proactively address and resolve issues related to stability studies, including troubleshooting analytical methods and managing deviations.
  • Cross-Functional Collaboration: Partner closely with Quality Assurance, Analytical Development, and Manufacturing teams to drive project success. Who You Are

Additional details

  • Join Roche, where every voice matters.
  • Our team of skilled associates and scientists manages critical analytical tasks, including stability studies, validations, and method transfers.
  • Cross-Functional Collaboration: Partner closely with Quality Assurance, Analytical Development, and Manufacturing teams to drive project success.
  • Language Skills: Business fluent English is a must, German is a plus
  • Are you ready to apply? A healthier future drives us to innovate.

Notes and original content

  • The Position
  • The Opportunity
  • Who You Are
  • Are you ready to apply?
  • Who we are
  • A healthier future drives us to innovate.
Apply now
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Company
Roche · Basel
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