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Quality Assurance Expert - Suppliers Management

Eingestellt von Michael Bailey Associates - Zurich

Gesuchte Skills: Support

Projektbeschreibung

We are currently recruiting for a Quality Assurance Expert to support a project in implementing and maintaining quality system and processes.

Major Accountabilities:
Defines and implements the business processes and SOPs necessary to maintain a robust Quality System within External Supply affecting the laboratory activities (eg management of changes, maintenance of testing monographs)
Support Implementation of Guidelines at external partners and suppliers
Lead programs and initiatives to implement changes and to remediate where required
Interprets stability data, analyzes trends, and provides scientifically sound conclusions to support assignment and monitoring of product shelf life, storage conditions, packaging and transport categories. Provide corrective actions to address immerging stability issues.
Support External Suppliers Qualification process
Support Tech Transfer assessments for analytical method transfers.
Lead QC aspects of Technical meetings with the External suppliers and establish good working relationships with clear communication and defined actions and goals.
Support assessments of analytical Change Control records for acceptability. Define studies needed to support the changes.
Interacts with the External Supplier to guarantee analytical results investigations are managed in agreement with standards
Ensure Testing Monographs are state-of-the-art with respect to technique and technology, and in line with registration documentation. Support programs and initiatives to implement changes to, and upgrade Testing Monographs where required
Support site readiness for Health Authority inspections & participate in audits on request.
Escalate any issues or instances of instability per escalation policy, and initiate any market action that is required.
Support analytical troubleshooting as needed.

Requirements:
University degree in Pharmacy, Biochemistry, Chemistry, or another related science
Min of 5 years experience in the pharmaceutical industry
Prior experiences in QC, method development, validation or stability testing
Thorough knowledge of cGMP requirements.
Thorough knowledge of cGMP, ICH guidelines, regulatory requirements & risk management.
Good leadership skills and experiences in leading project teams
Please send your CV

Michael Bailey International is acting as an Employment Business in relation to this vacancy.

Projektdetails

  • Einsatzort:

    Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    12 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

  • Skills:

    support

Michael Bailey Associates - Zurich