Quality Manager

Reference Number: 1009090-W
Type of placement: Contract, 16 Months
Location: Switzerland, North East / Central

Introduction:

Manage projects and/or processes and allocated resources to support departmental
projects and objectives according to agreed timelines and standards and assure
compliance with GMP is maintained

 

Main Responsibilities:

  • Manage portfolio of projects, support a discipline and/or provide a service. If applicable, may provide functional expertise in area of responsibility.
  • Review and recommend disposition of deliverables (e.g. procedures, records, third party work, contractors, clinical trial material, components) and related tools (e.g. IT, document systems, training tools, facility validation) to ensure
  • GMP compliance. With training and specific delegation may also approve relevant deliverables.
  • Support project related activities (e.g. interpret results, evaluate data, draw
  • relevant conclusions).
  • Perform inspections and audits as required
  • Contribute to the evaluation of new QA tools.
  • Write GMP relevant documents in own area of responsibility (e.g, SOPs with
  • global applicability).
  • Supervise 0-3 direct/indirect reports or a team.
  • Provide support to  line functions in GMP compliance related issues (e.g.
  • training, document management) .
  • Meet internal and external guidelines regarding quality and safety (quality
  • manuals, regulatory cGMP guidelines, health authority guidance’s, SOPs, HSE,
  • etc). Promote and enforce compliance to guidelines.. If managing associates,
  • ensure same for them.
  • Support project management functions as a sub-team member or in
  • preparation for a PAI.
  • Lead and support direct reports in line with values and behaviour
  • including objectives setting, performance evaluations, development planning
  • and participate in recruiting process.

 

 

Qualifications and Experience:

  • 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 site-language desirable
  • At least 2 years of relevant experience.
  • Ability to negotiate and communicate .
  • Sound scientific, technical and regulatory knowledge in a specific area.
  • VerygoodknowledgeofcGMPs,workingknowledge
    of safety and environmental regulations and guidelines.
  • Good knowledge of drug development .
  • Good organizational skills.
  • Good ability to analyze and evaluate GMP compliance

 

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