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Associate Quality Manager

Eingestellt von Harvey Nash IT Recruitment Switzerland

Gesuchte Skills: Support

Projektbeschreibung

Harvey Nash is looking for a Associate Quality Manager for a 8+ month project in Switzerland.

The role is to support the supervisor in timely release of GMP relevant documents by an appropriate review and addressing of gaps and questions. Support departmental projects and objectives according to agreed timelines and standards in the given area of competency and supports adherence to compliance with GMP in TRD.

You are responsible for

- Performing review of GMP relevant documents for compliance with SOPs across several customer groups (eg manufacturing or packaging master documents, batch records for material manufactured and/or packaged internally or at contractors, TEDI documents, SOPs, analytical raw data, analytical methods, analytical validation protocols and reports, etc.).
- Performing review and approval of GMP relevant documents derived from approved sources (eg analytical working sheet templates, GLIMS specifications)
- Supervising 0-3 direct/indirect reports or a team
- Negotiating deficiencies in GMP documents with the line unit
- Recognizing complex deficiencies in GMP documents, reporting them to supervisor, suggesting actions and supervise agreed follow-up; Proposing and surveying implementation of agreed preventive actions.
- Acting as contact person for QA questions of quality relevant electronic systems (eg IMOS, GLIMS, TQW, QP database, TEDI, ESOPS, Pathlore), and/or as a contact person to the needs of the line unit (eg CoA needs from different customers; TEDI formats, etc.)
- Writing and completing GMP relevant documents in own area of responsibility (eg CoAs, CoCs, BRR sheets, test scripts, SOPs with extended applicability)
- Performing statistical interpretation of trending data collected by QA (eg in TQW or audit database); Compiling trending reports and suggest conclusions
- Collaborating with other associates to support the service function of QA.
- Evaluating new QA tools (eg IT systems, processes)
- Participating in knowledge exchange within and outside of TRD
- Participating in training and coaching of new and temporary employees in QA and from associated line functions
- Leading and supporting direct reports in line with Novartis values and behavior including objectives setting, performance evaluations, development planning and participate in recruiting process

Requirements

- Minimum Education: Basic degree in laboratory, manufacturing or relevant discipline (eg apprenticeship, Bachelor or equivalent; Associates of Arts degree) Desirable Education: Basic degree in scientific or relevant discipline (advanced technical college, BA/BS or equivalent
- At least 5 years of experience in a corresponding line unit function (eg laboratory, manufacture, packaging, IT
- Negotiation and communication skills to address GMP related questions with the line unit experts, in order to maintain GMP records in a compliant status
- Sound scientific, technical and regulatory knowledge in a specific area
- Detailed knowledge of relevant GMPs, working knowledge of safety and environmental regulations and guidelines
- Good knowledge of drug development
- Good organizational skills
- Proven ability to analyze and evaluate GMP compliance
- Knowledge and flexibility to work with relevant IT system

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

  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    8months +

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

  • Skills:

    support

Harvey Nash IT Recruitment Switzerland