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Manufacturing Expert

Eingestellt von Harvey Nash IT Recruitment Switzerland

Gesuchte Skills: Support

Projektbeschreibung

Job title: Manufacturing Expert
Period: 01/09/2018 to 31/12/2018
Localisation: Stein
Workload: 100%

JOB DESCRIPTION:
As part of the drug product development, the Manufacturing Expert represents in the development teams the GMP manufacturing of clinical supplies and provides expert support for all GMP aspects in development projects and in external and internal GMP audits. He/she provides front line expert support for all process-specific issues within one or more production steps, ensures execution of processes on-time and continuously improves quality in compliance to cGMPs, SOPs and applicable guidelines.

THE MAIN ACCOUNTABILITIES ARE:
.Responsible for the independent planning and supervision of clinical supply in adherence with GMP requirements and project timelines
.Delivers GMP compliant documentation and supports worldwide registration processes
.Provides front line support for manufacturing, focusing on manufacturing processes and executing each batch safely and on time, in compliance with the batch instructions and quality requirements
.Drives process related troubleshooting, leads product and process related investigations and deviations, including complaints actions
.Ensures that process technical batches generate sufficient process knowledge by thoroughly testing critical variables
.Maintains their processes at inspection readiness level and provides the necessary support in any internal or external audit
.Ensures that all critical and significant parameters are within written instruction (ie Master Batch Record, Validation Plan)
.Supports the execution of process validations, re-validations and short-term improvement projects

MINIMUM REQUIREMENTS:
.MSc. or equivalent (PhD desirable) in science with focus on pharmaceutical technology (eg Pharmacy, Chemistry, Biochemistry, Biotechnology)
.Minimum 3 years of industry experience in dosage forms development and/or GMP manufacturing of dosage forms (experience with sterile, parenteral depot and/or topical dosage forms are desirable)
.Profound understanding of regulatory and cGMP requirements as well as expertise in the development of drug delivery systems
.Fluent in German and English (oral and written)

Are you available immediately, have experience working in pharmaceutical area?
Please send your complete CV to (see below) For further details feel free to call me. I am looking forward to receiving your application.

Projektdetails

  • Einsatzort:

    Stein, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

  • Skills:

    support

Harvey Nash IT Recruitment Switzerland