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Quality Assurance Specialist

Eingestellt von Harvey Nash IT Recruitment Switzerland

Gesuchte Skills: Support, Natural, Client

Projektbeschreibung

Position: Quality Assurance Specialist

For a 6 month project with a pharma/medical device client in Bern, we are looking ASAP for a Quality Assurance Specialist.

Tasks:

* Ensuring that products, systems and facilities are in state of sustainable compliance with the requirements of cGMP and regulatory authorities.
* Responsible for all quality matters related to the activities performed in the production and during process development.
* Assure efficient and effective quality assurance activities at required cGMP level.
* Assure that the products are manufactured according to cGMP requirements.
* Together with the team, support operations and/or development with cGMP guidance on all strategic decisions.

Essential duties Operational
* Ensuring compliance of products, processes, systems and equipment with global and local guidelines and procedures as well as with legal or regulatory requirements.
* Review and approval of SOPs, WOIs, TEIs, FOBs, RARs and other quality related documents.
* Review and approve Raw Materials.
* Perform batch record review and batch disposition.
* Review, assess and approve local Change Controls.
* Review and assess global Change Controls.
* Review and approve event and deviation reports. Assess event and deviation reports for any need of escalation to the Manager Quality Development.
* Ensure definition of appropriate and effective CAPAs with appropriate timelines and ensure timely implementation.
* Ensure appropriate coverage of CAPAs by effectiveness checks, follow up their execution and evaluate the results.
* Support Manager Quality Development in evaluation of PTCs and ADRs.
* Review and approval of CAPAs.
* Review and approval of investigation, events and deviations reports.
* Review and approval of SOPs, WOIs, TEIs, FOBs, RARs and other quality documents.
* Definition of quality related corrective and preventive actions.

Responsibilities As described before.
Performance Measurement Fulfillment of duties and tasks as described before and as to be defined in the yearly

Requirements:

* Multilingual at least German and English, written and spoken
* Experience in quality assurance of biological or pharmaceutical products according to cGMP requirements.
* University degree in natural sciences, medicine or pharmacy or
professional scientific, medicinal or pharmaceutical training and several years working experience under cGMP.

Quality:
* Know how of quality assurance principles (cGMP).
* Know how of biological manufacturing processes.
* Profound know how of Quality Assurance.
* Inspection experience.
* Know how of risk management.

Management Skills:
* Analytical thinking and problem-solving ability.
* Communication ability and Good negotiation skills.
* Time and self-management

Projektdetails

  • Einsatzort:

    Bern, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Harvey Nash IT Recruitment Switzerland