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Lead and coordinate QC projects, manage sample logistics, create and review documentation, ensure goods meet standards, support key initiatives, ensure compliance with guidelines.
Lead statistical activities for clinical trials and data analyses, provide expertise to cross functional teams, ensure quality and accuracy of statistical deliverables, develop and maintain SAS programs, stay updated with regulatory guidelines, mentor junior statisticians.
The Freelance/Contract Senior Process Engineer role at ProPharma involves supporting continuous improvement efforts within a GMP setting, providing leadership on CAPA's and deviations, managing processes, and working across the QA team to ensure quality operational tasks are completed successfully. The role requires further education in life sciences, experience in a GMP setting within the biological area, fluency in English, and the ability to work on a hybrid basis in Leiden, Netherlands.
Support continuous improvement efforts within a GMP setting, lead team members on CAPA's and deviations, manage processes and timelines, support QA team, and coach colleagues in GMP.
Assure complaint records meet global requirements, review and investigate non-medical complaint content, ensure compliance with regulatory requirements, interface with various stakeholders, provide quality customer service
The Quality Specialist position supports the delivery of Medical Information, Pharmacovigilance, and/or Clinical services, to assure ongoing compliance with quality and industry regulatory requirements. Essential functions include generating reports, analyzing deviations, developing corrective actions, and supporting audits.
Senior Manager role at ProPharma focusing on leading regulatory European CTA submission projects, managing client budgets, overseeing regulatory processes, and building client relationships. Requires advanced project management knowledge, strong attention to detail, and experience with clinical trial applications in Europe.
Seeking a Freelance/Contract Fachtechnisch verantwortliche Person (FvP) Consultant to work with clients in Switzerland on a key project. Responsibilities include ensuring license application success, compliance to regulations, running batch release activities, and stakeholder management. Must have a University degree in Science/Engineering, be a Responsible Person (FVP) in Switzerland, fluent in German and English, and have direct exposure to working with Biological projects as an FVP.
Principal Engineer responsible for managing and executing capital projects, overseeing construction and renovation activities, and ensuring compliance with safety regulations. Works closely with various departments and vendors to deliver high-quality infrastructure solutions. Manages project scopes, budgets, schedules, and stakeholder approvals. Provides contractor oversight, communicates project progress, and ensures projects are completed on time and within budget.
The Principal Biostatistician at ProPharma is responsible for leading statistical activities for clinical trials, providing statistical expertise to cross functional teams, ensuring quality and accuracy of statistical deliverables, and mentoring junior statisticians.
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