Quality Control Project Lead
Posted 2 hours 4 minutes ago by Elan Personal AG
Permanent
Not Specified
Laboratory Jobs
Not Specified, Switzerland
Job Description
Quality Control Project Lead
Roche Switzerland bridges the gap between pharmaceuticals and diagnostics. Important research and development functions are located here. For our long-term client, F. Hoffmann-La Roche AG in Basel, we are looking for a
Quality Control Project Lead
Background:
Global Technical Development (PTD) is an organization of over two thousand people globally that are integral for the mission of Roche to develop meaningful medicines for patients. Therefore, PTD actively collaborates and develops creative technical solutions to bridge early- stage, late-stage and commercial product needs. 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, teamwork, dedication, and mutual respect and contributes every single day, continuously improving what it does. Synthetic Molecules Technical Development (PTDC) brings a broad range of experience across drug substance (DS), drug product (DP), analytical sciences and Manufacturing Science & Technology (MS&T), and collaborates closely with key partners in the departments Research and Early Development (pRED / gRED), Small and Large Molecules (PTC, PTB), PTD and MS&T across the manufacturing network. This position on offer is located in Analytical Development Synthetic Molecules within Pharma Technical Development.
Analytical Development is responsible for the development of resource and cost efficient analytical methods for all materials used during drug manufacturing using state of the art methodologies such as e.g. High-performance liquid chromatography (HPLC), Gas
Chromatography (GC), Ion Chromatography (IC), Mass Spectrometry (MS), and others. The ultimate goal of the work is a robust control strategy to release pharmaceutical products for clinical trials, and finally for commercial supply. The QC-Section within the Analytical Development Department is responsible for the Release of Materials based on the GMP compliant execution of Analyses of Inprocess controls, raw materials, intermediates, APIs and Drug products.
Tasks & Responsibilities:
Work in a modern quality control organization in compliance with cGMP regulations
Cooperation with internal and/or external partners of Analytical Development
Active participation in shaping the working methods of the analytical group
Comprehensive analytical support for supply plants for API and drug product for clinical use
Critical evaluation of own work results
Support the analytical group by fulfilling cross-laboratory tasks and project tasks ( standard management, CSV business process owner of analytical applications)
Implementing and fully complying with relevant Roche policies, procedures, and standards in the areas of safety, health, and environmental protection
Ensuring that laboratory employees are informed of all relevant SHE requirements and their implementation
Ensuring an appropriate GMP standard in the laboratory
Scientific and regulatory documentation of the work done
Must Haves:
Bachelor's or Master's degree in Natural Sciences OR a Laboratory Technician with 10+ years of high-level GMP experience
3-5 years of professional industry experience with a core focus on Analytical Chemistry
Practical experience working under cGMP regulations is required
Proficiency in laboratory-specific software (e.g., Waters Empower, Metrohm Tiamo, or Labware LIMS)
English (Fluent/Mandatory). German language skills are considered a significant advantage
Nice to Have:
Roche Experience
Experience in roles such as Lab Head, Analytical Project Manager, or equivalent
What you will be offered:
An opportunity to work in one of the world's most important pharmaceutical companies
Modern campus with plenty of green spaces and meeting areas
Central location in Basel
Varied job profile
Further training opportunities through temptraining
Working in a dynamic and motivated team
If you are interested please send your application documents addressed to Ms Afonso.
Basel-Stadt Aargau Pharma Science GMP Quality Control QC-PL Laboratory Waters Empower Metrohm Tiamo LIMS jidaafe14ca jit0520a jiy26a
Roche Switzerland bridges the gap between pharmaceuticals and diagnostics. Important research and development functions are located here. For our long-term client, F. Hoffmann-La Roche AG in Basel, we are looking for a
Quality Control Project Lead
Background:
Global Technical Development (PTD) is an organization of over two thousand people globally that are integral for the mission of Roche to develop meaningful medicines for patients. Therefore, PTD actively collaborates and develops creative technical solutions to bridge early- stage, late-stage and commercial product needs. 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, teamwork, dedication, and mutual respect and contributes every single day, continuously improving what it does. Synthetic Molecules Technical Development (PTDC) brings a broad range of experience across drug substance (DS), drug product (DP), analytical sciences and Manufacturing Science & Technology (MS&T), and collaborates closely with key partners in the departments Research and Early Development (pRED / gRED), Small and Large Molecules (PTC, PTB), PTD and MS&T across the manufacturing network. This position on offer is located in Analytical Development Synthetic Molecules within Pharma Technical Development.
Analytical Development is responsible for the development of resource and cost efficient analytical methods for all materials used during drug manufacturing using state of the art methodologies such as e.g. High-performance liquid chromatography (HPLC), Gas
Chromatography (GC), Ion Chromatography (IC), Mass Spectrometry (MS), and others. The ultimate goal of the work is a robust control strategy to release pharmaceutical products for clinical trials, and finally for commercial supply. The QC-Section within the Analytical Development Department is responsible for the Release of Materials based on the GMP compliant execution of Analyses of Inprocess controls, raw materials, intermediates, APIs and Drug products.
Tasks & Responsibilities:
Work in a modern quality control organization in compliance with cGMP regulations
Cooperation with internal and/or external partners of Analytical Development
Active participation in shaping the working methods of the analytical group
Comprehensive analytical support for supply plants for API and drug product for clinical use
Critical evaluation of own work results
Support the analytical group by fulfilling cross-laboratory tasks and project tasks ( standard management, CSV business process owner of analytical applications)
Implementing and fully complying with relevant Roche policies, procedures, and standards in the areas of safety, health, and environmental protection
Ensuring that laboratory employees are informed of all relevant SHE requirements and their implementation
Ensuring an appropriate GMP standard in the laboratory
Scientific and regulatory documentation of the work done
Must Haves:
Bachelor's or Master's degree in Natural Sciences OR a Laboratory Technician with 10+ years of high-level GMP experience
3-5 years of professional industry experience with a core focus on Analytical Chemistry
Practical experience working under cGMP regulations is required
Proficiency in laboratory-specific software (e.g., Waters Empower, Metrohm Tiamo, or Labware LIMS)
English (Fluent/Mandatory). German language skills are considered a significant advantage
Nice to Have:
Roche Experience
Experience in roles such as Lab Head, Analytical Project Manager, or equivalent
What you will be offered:
An opportunity to work in one of the world's most important pharmaceutical companies
Modern campus with plenty of green spaces and meeting areas
Central location in Basel
Varied job profile
Further training opportunities through temptraining
Working in a dynamic and motivated team
If you are interested please send your application documents addressed to Ms Afonso.
Basel-Stadt Aargau Pharma Science GMP Quality Control QC-PL Laboratory Waters Empower Metrohm Tiamo LIMS jidaafe14ca jit0520a jiy26a