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Quality Assurance Specialist

Eingestellt von Harvey Nash IT Recruitment Switzerland

Gesuchte Skills: Support, Natural, Client


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.


* 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


* 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.

* 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


  • Einsatzort:

    Bern, Schweiz

  • Projektbeginn:


  • Projektdauer:

    Keine Angabe

  • Vertragsart:


  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Harvey Nash IT Recruitment Switzerland

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