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QA Manager
Eingestellt von Harvey Nash IT Recruitment Switzerland
Gesuchte Skills: Support, Client
Projektbeschreibung
Harvey Nash is looking for a 7 + month project in Switzerland.
The role is to manage projects and/or processes and allocated resources to support departmental projects and objectives according to agreed timelines and standards and assure compliance with cGMP is maintained in TRD.
You are responsible for
- Approval of GMP relevant documents and decision making according to current SOP for the authority of QA associate
- Managing technical complaints, deviations, investigations, CAPAs and change requests
- Contributing to or writing trending reports for complaints/deviations and processes of line units and recommends necessary actions to supervisor
- Quality system: writing/reviewing SOPs
- Supporting and driving in QA and with the line unit process improvements
- Providing support to TRD line functions in GMP compliance related issues (eg training, document management)
- Supporting internal audits of the client and audits of third party packaging and labeling as required
- Meeting internal and external guidelines regarding quality and safety (eg quality manuals, regulatory cGMP guidelines, health authority guidance, SOPs, HSE)
- Promoting and enforcing compliance to guidelines
- Contributing to the evaluation of new QA tools
- Providing functional expertise in area of responsibility
Requirements
- Minimum: Technician with continuing education (EU) or BS/MS (US) or equivalent basic degree in scientific or relevant discipline (BS or equivalent); Desirable: Advanced degree in scientific or relevant discipline (MS or equivalent)
- Good knowledge in English (oral and written) required; fluent in German
- At least 2 years of relevant experience
- Ability to negotiate and communicate
- Sound scientific, technical and regulatory knowledge in a specific area (ideally in the area of clinical packaging)
- Very good knowledge of cGMP, working knowledge of safety and environmental regulations and guidelines
- Good knowledge of drug development
- Good organizational skills
- Good ability to analyze and evaluate GMP compliance
Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred) to (see below) For further details feel free to call me. I am looking forward to receiving your application.
The role is to manage projects and/or processes and allocated resources to support departmental projects and objectives according to agreed timelines and standards and assure compliance with cGMP is maintained in TRD.
You are responsible for
- Approval of GMP relevant documents and decision making according to current SOP for the authority of QA associate
- Managing technical complaints, deviations, investigations, CAPAs and change requests
- Contributing to or writing trending reports for complaints/deviations and processes of line units and recommends necessary actions to supervisor
- Quality system: writing/reviewing SOPs
- Supporting and driving in QA and with the line unit process improvements
- Providing support to TRD line functions in GMP compliance related issues (eg training, document management)
- Supporting internal audits of the client and audits of third party packaging and labeling as required
- Meeting internal and external guidelines regarding quality and safety (eg quality manuals, regulatory cGMP guidelines, health authority guidance, SOPs, HSE)
- Promoting and enforcing compliance to guidelines
- Contributing to the evaluation of new QA tools
- Providing functional expertise in area of responsibility
Requirements
- Minimum: Technician with continuing education (EU) or BS/MS (US) or equivalent basic degree in scientific or relevant discipline (BS or equivalent); Desirable: Advanced degree in scientific or relevant discipline (MS or equivalent)
- Good knowledge in English (oral and written) required; fluent in German
- At least 2 years of relevant experience
- Ability to negotiate and communicate
- Sound scientific, technical and regulatory knowledge in a specific area (ideally in the area of clinical packaging)
- Very good knowledge of cGMP, working knowledge of safety and environmental regulations and guidelines
- Good knowledge of drug development
- Good organizational skills
- Good ability to analyze and evaluate GMP compliance
Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred) to (see below) For further details feel free to call me. I am looking forward to receiving your application.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Sonstiges