Quality Assurance Specialist

Vor 7 Tagen

Zürich, Schweiz Tech'Firm Industrie AG Vollzeit

We are looking for the following qualifications and experience:

Core Responsibilities:

  • Verification of the companies compliance with ISO/cGMP quality system requirements as well as knowledge of PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1.
  • Provide immediate support to operations and quality control staff to address compliance related concerns (QA on-the-floor support).
  • Make independent quality-related decisions based on regulatory and compliance knowledge and provide independent quality support to project teams. Audit internal quality system elements in manufacturing and operational support areas.
  • Provide oversight for compliance of Change Controls, CA/PA and investigations, OOS and deviations.
  • Perform external audits of suppliers/vendors/off-site facilities.
  • Act as a customer interface during on-site audits, conference calls and other standard means of communication.
  • Independently identify and manage special projects or QA compliance functions as agreed upon with QA management.
  • Prioritize and manage a variety of projects simultaneously.
  • May need to lead and direct the work of others.
  • Review and approve validation documents.
  • Review and Master Batch Records (MBR) and supporting documents.
  • Perform review/release of batch records, as needed.

Qualifications and Experience:

  • Master or Engineering degree in Life science, Biotechnology or Pharmaceutical area
  • Min. 3-5 years work experience
  • Direct QA commercial drug substance/drug product experience required or an equivalent amount of aseptic processing and cell therapy manufacturing experience.
  • GMP compliance and Part 11 compliance knowledge preferred.
  • Experience with oversight of aseptic processing and the associated international aseptic processing regulations.
  • Excellent written and oral communication to include accurate and legible documentation skills.
  • Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects.

Interested to have a first chat and get on board at Techfirm? Then don't hesitate to submit your application together with your CV indicating your previous experience related to this position.

  • Quality Assurance Specialist

    vor 2 Wochen

    Zürich, Zürich, Schweiz Tech'Firm Industrie AG Vollzeit

    Join our team at TechFirm Industrial Services as: QUALITY ASSURANCE SPECIALIST (w/m/d) in the GMP environment here in Switzerland Quality Assurance SpecialistWe are looking for the following qualifications and experience: Core Responsibilities:Verification of the companies compliance with ISO/cGMP quality system requirements as well as knowledge of PICS...

  • Quality Specialist

    vor 4 Wochen

    Zürich, Zürich, Schweiz On AG Vollzeit

    ‹ Back to jobsQuality SpecialistLocation: ZurichApply for this roleCosting & SourcingCosting & SourcingIn shortAs our Quality Specialist you will be working in the field of quality and warranty management and in this role you will be innovating the way we do things to make On smarter, more agile and to continuously improve our products. You will be in a...

  • Quality Specialist

    vor 2 Monaten

    Zürich, Zürich, Schweiz On AG Vollzeit

    ‹ Back to jobsQuality SpecialistLocation: ZurichApply for this roleCosting & SourcingCosting & SourcingIn shortAs our Quality Specialist you will be working in the field of quality and warranty management and in this role you will be innovating the way we do things to make On smarter, more agile and to continuously improve our products. You will be in a...

  • Quality Specialist

    vor 4 Wochen

    Zürich, Zürich, Schweiz On Vollzeit

    Team for Career SiteCosting & SourcingIn shortAs our Quality Specialist you will be working in the field of quality and warranty management and in this role you will be innovating the way we do things to make On smarter, more agile and to continuously improve our products. You will be in a key role to manage product non-conformances and initiate and drive...

  • Quality Specialist

    vor 2 Monaten

    Zürich, Zürich, Schweiz On Vollzeit

    Team for Career SiteCosting & SourcingIn shortAs our Quality Specialist you will be working in the field of quality and warranty management and in this role you will be innovating the way we do things to make On smarter, more agile and to continuously improve our products. You will be in a key role to manage product non-conformances and initiate and drive...

  • Quality Specialist

    vor 4 Wochen

    Zürich, Schweiz On Vollzeit

    Team for Career Site Costing & Sourcing In short As our Quality Specialist you will be working in the field of quality and warranty management and in this role you will be innovating the way we do things to make On smarter, more agile and to continuously improve our products. You will be in a key role to manage product non-conformances and initiate and drive...

  • Quality Specialist

    vor 4 Wochen

    CH-8005 Zürich On AG Vollzeit

    ‹ Back to jobs Quality Specialist Location: ZurichApply for this roleCosting & SourcingCosting & Sourcing In short As our Quality Specialist you will be working in the field of quality and warranty management and in this role you will be innovating the way we do things to make On smarter, more agile and to continuously improve our products. You will be in...

  • Quality Specialist

    vor 1 Monat

    Zürich, Schweiz Wyss Zurich Vollzeit

    Job description As the Quality Specialist, you will play a pivotal role in ensuring the highest quality standards for our active medical devices, classified as class II. Your expertise will contribute in establishing and maintaining a robust Quality Management System (QMS) in compliance with ISO and 21 CFR Part and applicable regulatory requirements....

  • Quality Specialist

    vor 4 Wochen

    Zürich, Schweiz Wyss Zurich Vollzeit

    Job description As the Quality Specialist, you will play a pivotal role in ensuring the highest quality standards for our active medical devices, classified as class II. Your expertise will contribute in establishing and maintaining a robust Quality Management System (QMS) in compliance with ISO and 21 CFR Part and applicable regulatory requirements....

  • Senior Specialist – Quality

    vor 4 Wochen

    Zürich, Zürich, Schweiz On Vollzeit

    Team for Career SiteCosting & SourcingIn shortAs our Senior Quality Specialist you will be working in the field of quality and warranty management. In this role you will be innovating the way we do things to make On smarter, more agile and to continuously improve our products. You will be in a key role to manage product non-conformances and initiate and...

  • Senior Specialist – Quality

    vor 2 Monaten

    Zürich, Zürich, Schweiz On Vollzeit

    Team for Career SiteCosting & SourcingIn shortAs our Senior Quality Specialist you will be working in the field of quality and warranty management. In this role you will be innovating the way we do things to make On smarter, more agile and to continuously improve our products. You will be in a key role to manage product non-conformances and initiate and...

  • Manager Quality Assurance

    vor 2 Wochen

    Zürich, Zürich, Schweiz HELM AG Vollzeit

    In the business unit Pharma we develop generic drugs. The Swiss Hub in Zürich (HELM Swiss GmbH) is responsible for the commercial and quality handling of a selection of products for export from Switzerland, including the USA. We are looking to add to our team a Scientist with international experience, in the function of Quality Assurance Manager and ...

  • Manager Quality Assurance

    vor 2 Wochen

    Zürich, Zürich, Schweiz HELM AG Vollzeit

    In the business unit Pharma, we specialize in developing generic drugs. Our Swiss Hub in Zürich (HELM Swiss GmbH) oversees the commercial and quality aspects of a range of products destined for export, including to the USA. We are currently seeking a Scientist with solid international experience to join our team as a Quality Assurance Manager (m/f/d).Your...

  • Quality Assurance Manager

    vor 2 Wochen

    Zürich, Zürich, Schweiz Rheinmetall Air Defence AG Vollzeit

    **Quality Assurance Manager (m/w/d)****Rheinmetall Air Defence AG in Zürich**- Rheinmetall- /- **Quality Assurance Manager (m/w/d)**- Ref.Nr.:- **CH00672**- Anstellungsart:- **Vollzeit**- Vertragsart:- **Unbefristeter Vertrag**WOFÜR WIR SIE SUCHENIn Ihrer Position als Quality Assurance Manager (m/w/d) unterstützen Sie das Team der projektbezogenen...

  • Quality Assurance Manager

    vor 2 Wochen

    Zürich, Zürich, Schweiz Rheinmetall Air Defence AG Vollzeit

    **Quality Assurance Manager (m/w/d)****Rheinmetall Air Defence AG in Zürich**- Rheinmetall- /- **Quality Assurance Manager (m/w/d)**- Ref.Nr.:- **CH00672**- Anstellungsart:- **Vollzeit**- Vertragsart:- **Unbefristeter Vertrag**WOFÜR WIR SIE SUCHENIn Ihrer Position als Quality Assurance Manager (m/w/d) unterstützen Sie das Team der projektbezogenen...

  • Quality Assurance Manager

    vor 2 Wochen

    Zürich, Zürich, Schweiz Sonova Vollzeit

    Who we areYou enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team.Above all, you want your work to matter: Welcome to our world At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life's unforgettable...

  • Senior Specialist

    vor 4 Wochen

    CH-8005 Zürich On AG Vollzeit

    ‹ Back to jobs Senior Specialist - Quality Location: ZurichApply for this roleCosting & SourcingCosting & Sourcing In short As our Senior Quality Specialist you will be working in the field of quality and warranty management. In this role you will be innovating the way we do things to make On smarter, more agile and to continuously improve our products....

  • Quality Assurance Manager

    vor 2 Wochen

    Zürich, Zürich, Schweiz Rheinmetall Air Defence AG Vollzeit

    **Quality Assurance Manager (m/w/d)****Rheinmetall Air Defence AG in Zürich**- Rheinmetall- /- **Quality Assurance Manager (m/w/d)**- Ref.Nr.:- **CH00571**- Anstellungsart:- **Vollzeit**- Vertragsart:- **Unbefristeter Vertrag**WOFÜR WIR SIE SUCHEN**In Ihrer Position als Quality Assurance Manager (m/w/d) unterstützen Sie das Team der Qualitätssicherung,...

  • Team Leader Quality Assurance and Customer Quality 80 – 100%

    vor 2 Wochen

    Zürich, Zürich, Schweiz HITACHI ENERGY LTD Vollzeit

    Description : Hitachi Energy, High Voltage Products, is renowned worldwide as a specialist in power transmission and distribution. Our unit Gas Insulated Switchgears (GIS), based in Zürich-Oerlikon, is active in the development and production of gas insulated switching systems. We ensure the high reliability of our systems by using state-of-the-art...

  • Quality Assurance Manager

    vor 2 Wochen

    Zürich, Zürich, Schweiz Rheinmetall Air Defence AG Vollzeit

    **Quality Assurance Manager (m/w/d)****Rheinmetall Air Defence AG in Zürich**- Rheinmetall- /- **Quality Assurance Manager (m/w/d)**- Ref.Nr.:- **CH00672**- Anstellungsart:- **Vollzeit**- Vertragsart:- **Unbefristeter Vertrag**WOFÜR WIR SIE SUCHENIn Ihrer Position als Quality Assurance Manager (m/w/d) unterstützen Sie das Team der projektbezogenen...