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QA Compliance Manager - TRD, Contract, Switzerland
Eingestellt von Michael Bailey Associates - UK Contracts
Gesuchte Skills: Client, Support
Projektbeschreibung
For our Life Science client in Basel, we are seeking a QA Compliance Manager
Start Date: ASAP
End Date: 30th November 2016 + extensions
Location: Basel
Language: English and good German
Our Life Science client are seeking a QA Compliance manage, to mange projects and processes supporting departmental objectives and projects, in accordance to agreed timelines and standards - assuring compliance with GMP is maintained in Technical Researchalso providing functional expertise in area of responsibility
- Review and approve deliverables and associated tools, ensuring GMP compliance
- Represent TRD QA in initiatives
- Lead project-related activities
- Write, review and approve documents (including SOPs) and related tools, ensuring GMP compliance
- Perform relevant inspections and audits
- Contribute to the evaluation of new QA tools
- Provide support to TRD line functions in areas related to GMP compliance
- Meet internal and external guidelines related to quality and safety
- Support project management functions
- Contribute to internal compliance policy
ADDITIONAL TASKS:
- Approve GMP relevant documents according to current SOP
- Manage deviations, investigations, CAPAS and contribute to trending reports for deviation/change requests for products and processes or TRD GMP line
- Contribute to First Time Right performance reports
- Support internal client audits and third party packaging audits
- Fulfil SME role as defined in area Matrix
YOUR EXPERIENCE:
- BSc in Scientific/Relevant discipline - MSc is preferred
- 5+ years experience in TRD, production or QA
- Good cGMP knowledge - proven ability to analyse and evaluate GMP compliance
- Good scientific, technical and regulatory knowledge
- Fluency in English and German
- Strong organisational skills
We welcome applications of consultants' who match most of the above requirements and are available on a short notice. There is a competitive Hourly rate available for the contract; alternative market rates are also welcome.
Please note there is a job description available on request.
We hope the role will be of interest to you and understand that further information may be required before making an application to the end client, please feel free to send either your full name, contact details or a complete CV via this website and I will endeavour to get back to you with further information on the role and answer any questions you may have.
Kind regards,
Neha Sharma
Pharmaceutical & Life Sciences Business Developer
Recruiting Team MBA,
Michael Bailey Associates
Key words: Quality, QA, TRD, SOP, GMP, compliance, German, SME, CAPA, cGMP, HSE, Regulatory affairs, Technical development, project management, validation, audits, Basel
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Start Date: ASAP
End Date: 30th November 2016 + extensions
Location: Basel
Language: English and good German
Our Life Science client are seeking a QA Compliance manage, to mange projects and processes supporting departmental objectives and projects, in accordance to agreed timelines and standards - assuring compliance with GMP is maintained in Technical Researchalso providing functional expertise in area of responsibility
- Review and approve deliverables and associated tools, ensuring GMP compliance
- Represent TRD QA in initiatives
- Lead project-related activities
- Write, review and approve documents (including SOPs) and related tools, ensuring GMP compliance
- Perform relevant inspections and audits
- Contribute to the evaluation of new QA tools
- Provide support to TRD line functions in areas related to GMP compliance
- Meet internal and external guidelines related to quality and safety
- Support project management functions
- Contribute to internal compliance policy
ADDITIONAL TASKS:
- Approve GMP relevant documents according to current SOP
- Manage deviations, investigations, CAPAS and contribute to trending reports for deviation/change requests for products and processes or TRD GMP line
- Contribute to First Time Right performance reports
- Support internal client audits and third party packaging audits
- Fulfil SME role as defined in area Matrix
YOUR EXPERIENCE:
- BSc in Scientific/Relevant discipline - MSc is preferred
- 5+ years experience in TRD, production or QA
- Good cGMP knowledge - proven ability to analyse and evaluate GMP compliance
- Good scientific, technical and regulatory knowledge
- Fluency in English and German
- Strong organisational skills
We welcome applications of consultants' who match most of the above requirements and are available on a short notice. There is a competitive Hourly rate available for the contract; alternative market rates are also welcome.
Please note there is a job description available on request.
We hope the role will be of interest to you and understand that further information may be required before making an application to the end client, please feel free to send either your full name, contact details or a complete CV via this website and I will endeavour to get back to you with further information on the role and answer any questions you may have.
Kind regards,
Neha Sharma
Pharmaceutical & Life Sciences Business Developer
Recruiting Team MBA,
Michael Bailey Associates
Key words: Quality, QA, TRD, SOP, GMP, compliance, German, SME, CAPA, cGMP, HSE, Regulatory affairs, Technical development, project management, validation, audits, Basel
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Sonstiges