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Quality Technical Manager (German and English)
Eingestellt von Randstad (Schweiz) AG
Gesuchte Skills: Client, Support
Projektbeschreibung
Quality Technical Manager
Randstad Professionals in Zurich is actively looking for a Senior Quality Technical Manager to join their international pharmaceutical client in Basel, Switzerland. This candidate will need to be able to travel 10-25% of the time. It is critical that the QA Technical Manager has experience in small molecules.
Description:
The purpose of this position is to provide quality oversight and expertise for the selection, implementation and management of Contract Manufacturing Organizations (CMOs) used for the manufacture of clinical small molecule GMP intermediates, APIs and drug products. This position leads quality system development and implementation as well as business process improvements. The position will also provide QA Validation support for Small Molecule programs and may be part of Technical Development (TDT) teams.
Responsibilities include but are not limited to:
- Representation of the External Quality Small Molecules on TDT teams as needed.
- Reviewing of Master Batch Records
- Preparation of Quality Agreements
- Provision of technical expertise and guidance to the External Quality Small Moleculs Organization by supporting or managing deviations and investigations
- Participation in the design, implementation and maintenance of qualify systems for small molecules
- Performing pre-approval inspection checklists at CMO's that will be manufacturing commercial materials for the client
Qualifications needed
- At least 10 years experience in pharmaceutical manufacturing, quality assurance or quality control
- At least 5 years of project experience in a quality role
- At least 3 years of experience in operating quality systems in pharmaceutical operations
- Deep understanding of internatioal cGMP Regulations
- Ability to travel between 15-20%
- German and English proficiency
If you're interested in this new project, please don't hesitate to send in your application
Good to know you!
Charlotte
Randstad Professionals in Zurich is actively looking for a Senior Quality Technical Manager to join their international pharmaceutical client in Basel, Switzerland. This candidate will need to be able to travel 10-25% of the time. It is critical that the QA Technical Manager has experience in small molecules.
Description:
The purpose of this position is to provide quality oversight and expertise for the selection, implementation and management of Contract Manufacturing Organizations (CMOs) used for the manufacture of clinical small molecule GMP intermediates, APIs and drug products. This position leads quality system development and implementation as well as business process improvements. The position will also provide QA Validation support for Small Molecule programs and may be part of Technical Development (TDT) teams.
Responsibilities include but are not limited to:
- Representation of the External Quality Small Molecules on TDT teams as needed.
- Reviewing of Master Batch Records
- Preparation of Quality Agreements
- Provision of technical expertise and guidance to the External Quality Small Moleculs Organization by supporting or managing deviations and investigations
- Participation in the design, implementation and maintenance of qualify systems for small molecules
- Performing pre-approval inspection checklists at CMO's that will be manufacturing commercial materials for the client
Qualifications needed
- At least 10 years experience in pharmaceutical manufacturing, quality assurance or quality control
- At least 5 years of project experience in a quality role
- At least 3 years of experience in operating quality systems in pharmaceutical operations
- Deep understanding of internatioal cGMP Regulations
- Ability to travel between 15-20%
- German and English proficiency
If you're interested in this new project, please don't hesitate to send in your application
Good to know you!
Charlotte
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Sonstiges