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QA Specialist

Eingestellt von Berry Technical

Gesuchte Skills: Support, Natural, Client

Projektbeschreibung

QA Specialist/6 Month Contract/Switzerland/760 CHF per day

Our client a key account and a global market leader is looking to take on a QA Specialist to:

*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 the company including training.
*Support inspection team during preparation, execution and follow up of inspections and audits.

Competencies Operational
*Review and approval of changes.
*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 the release of raw materials specification documentation.
*Review and approval of raw materials.
*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.

Non-Technical profile requirements:
*Some flexibility in working hours is required
*Must be able to work on multiple simultaneous tasks with limited supervision; -
*Quick learner, motivated self-starter
*Excellent customer service, interpersonal, communication and team collaboration skills
*Able to follow change management for internal guidelines.

Additional:
*Experience in quality assurance of biological or pharmaceutical products according to cGMP requirements.
*Ideally a University degree in natural sciences, medicine or pharmacy or
*Professional scientific, medicinal or pharmaceutical training and several years working experience under cGMP.

Language proficiencies:
English and German spoken and written

Projektdetails

  • Einsatzort:

    Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    6 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Berry Technical