Site Readiness QA Specialist

  • Beschäftigungsart Temporär - until further notice
  • Ort
    Yverdon-les-Bains
  • Referenz 207346-14-3
  • Beginn des Einsatzes Asap
  • Sektor Chemie & Life Sciences
  • Publikationsdatum 28.05.2021
  • Bewerben

Are you a QA professional interested in working for one of the most interesting names in High-Tech Biotech in Swiss Romande?

A challenging contract role has just opened at one of our leading clients offering a passionate quality specialist an opportunity to join a versatile team of professionals working on exciting projects in the biopharmaceutical manufacturing.

Site Readiness QA Specialist

Ihr Einsatz

* QA Operations:
o QA support for implementation of Manufacturing execution System (MES) implementation
o Review and approve MBRs, specifications and Material Master data
o Review executed batch records
o Manage deviations, CAPA and Change controls
o Support Risks assessments
o Support the creation and review of operational procedures,

* Raw Materials' Management:
o Conduct Supplier's audits
o Support establishment of Raw materials specification
o Review and approve Raw Material Master data
o Release Raw Materials
o QA oversight of Raw Material analytical method validation

* Quality Systems:
o Develop and compile quality metrics and Dashboards
o Conduct periodic trainings on electronic systems
o Support the Quality Systems initiatives

* Act within compliance and legal requirements as well as within company guidelines
* Foster the understanding and the application of Good Manufacturing Practices (cGMPs) by bioplant employees
* At all times work in a right first time and site readiness approaches for regulatory inspections (Swissmedic and International)
* Contribute positively to a strong culture of business integrity and ethics

Ihr Profil

* Bachelor's Degree in relevant field such as Chemical Engineering, Bio-engineering, Bioprocessing
* Speak, read and write in French and English
* Minimum of 3 years in a Quality Assurance role in a biopharmaceutical manufacturing environment
* Good knowledge of biotechnology processes and manufacturing
* Qualified auditor is a plus
* Demonstrated proficiency in cGMP as well as biopharmaceutical industry regulations.
* Proficiencies with the quality systems and electronic systems.

Interessiert?

Are you interested? To apply for this vacancy, just use the button ‘Apply' and complete application documents (cv, job references and proof of qualification) with your notice period and salary expectations. Please note that only online applications will be considered.

Manpower Life Sciences is a specialist group within the agency, connecting international and Swiss competent talent with job opportunities in pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Über Manpower
Manpower Schweiz weist über 55 Jahre Erfahrung in der Rekrutierung, Evaluierung und Vermittlung von temporären und festen Mitarbeitenden sowie der Erbringung von HR-Lösungen auf. Mit 50 Agenturen in allen Sprachregionen, 20 000 temporären Mitarbeitenden, 1500 Feststellenvermittlungen und über 5000 Kundenunternehmen aller Grössenordnungen und aus allen Wirtschaftszweigen gehört Manpower zu den Branchenführern in der Schweiz.
 
Unsere 3 Versprechen
„Wir lieben, was wir tun. Dank unserer Leidenschaft haben Sie die besten Einsatzchancen.“
„Wir mögen Menschen. Wie Sie. Darum setzen wir auf eine vertrauensvolle Zusammenarbeit.“
„Wir übernehmen Verantwortung. Das verschafft Ihnen Sicherheit und interessante Perspektiven.“
 
 

Ich will den Job!

Ihr/e Manpower-Berater/in
Inessa Duerst

Life Sciences Competence Center
Picassoplatz 4
4052 Basel

T: +41 58 307 2441



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