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Quality Assurance Manager

Eingestellt von Berry Technical

Gesuchte Skills: Support, Natural, Client

Projektbeschreibung

Quality Assurance Manager/£550 per day/Switzerland/6-12 Month Contract

Our client a global giant in the pharmaceutical industry is in search of a Quality Assurance manager to join the team.

The role will include:
* 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 release package (including samples).
* Review and approve certifications for Health Authorities.
* Support in compilation of the PQRs.
* cGMP compliance
* Manage and further develop the quality system.
* Increase cGMP understanding within Crucell including training.
* Support inspection team during preparation, execution and follow up of inspections and audits.
* Competencies Operational
* 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.
* Review of MBRs, Batch Production Records, including all supporting documentation (for example, test results)
* Compilation of batch dossier for batch release
* Perform QA release of batches and intermediates.
* Set batch status in LIMS and SAP excluding QP release.
* Take over equivalent competencies for other products if delegation approved by the qualified person.
* Requesting for blocking of equipment, processes and products.
* Definition of quality related corrective and preventive actions.
* Performance Measurement Fulfillment of duties and tasks as described before and as to be defined in the yearly performance talks.

*Requirements

General:

* Experience in quality assurance of biological or pharmaceutical products according to cGMP requirements.
* University degree in natural sciences, medicine or pharmacy
* Professional scientific, medicinal or pharmaceutical training and working experience under cGMP.
* Understanding of biological manufacturing processes.
* Inspection experience.
* Understanding of risk management.
* Analytical thinking and problem-solving ability.
* Communication ability and Good negotiation skills.
* German and English, written and spoken

Projektdetails

  • Einsatzort:

    Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    6 - 12 month

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Berry Technical