Senior Associate Supplier Quality specialist in Baar

veröffentlicht
Kontakt
Olivier Worch, Basel Professionals Health Care & Life Sciences
Jobtyp
Temporär
jetzt bewerben

job details

veröffentlicht
Ort
Baar, Zug
Sektor
Life Sciences
Jobtyp
Temporär
Referenznummer
13364
Kontakt
Olivier Worch, Basel Professionals Health Care & Life Sciences
Telefon
058 201 55 50

Stellenbeschreibung

Randstad Professionals is currently looking for a Quality Assurance Associate (focus on Supplier Quality) who will be assigned an interesting challenge for a major client based close to Zug.

This contract is a great opportunity to join a global group focusing on the Biotech sector. The initial assignment will start immediately and will last until April 2020.

Contract details:

Start Date:   ASAP

Requisition End Date:   April 2020

Job Summary:

Delegated Responsible Person according to Swiss Ordinance 812.212.1. When acting as a delegated Responsible Person, he is authorized to give directives (also towards management) in his area of responsibility for manufacturing sites in Germany and Switzerland. . Release and disposition of API, DS, DP for commercial and clinical Large Molecules/Small molecules products. Release of FG products. Ensure compliance for materials manufactured with respect to regulatory and GMP requirements. Further responsible for (but not limited to) review and verification of batch release documentation. Follow up with GEQ colleagues and cross-functional departments (i.e. EM, Logistics, Planning) on batch status, deviations, changes and CAPAs related to the batch documentation. 

Give advice on regulatory and compliance question to stakeholders. Review and perform QA approval on release relevant documents, Deviations, CAPAs, Change-Controls. Participate as a GEQ Release representative on cross-functional teams and projects with regard to the release process.

Responsibilities:

  • Release and disposition of batches, review and verification of batch release documentation according to local procedures and product specific checklist. Develop the relationship with the stakeholders. Maintain efficient and pertinent process flow. When acting as a delegated Responsible Person, he is authorized to give directives (also towards management) in his area of responsibility. Ensure compliance for materials manufactured with respect to regulatory and GMP requirements. (60%)

  • Provides technical guidance, assesses and requests means as necessary needed for Sets Individual performance and development goals.

  • Reviews and performs QA approval on release relevant documents, Deviations, CAPAs, Change-Controls. Cooperate cross-functional with relevant parties for timely closure of exceptions and ensure required documentation is effective. Perform Owning Department approvals in MyCIMS.

  • Participate as a GEQ Release representative on cross-functional teams and projects. Give advice on regulatory and compliance question to stakeholders. Address potential gaps for processes or practices within teams and projects to avoid incompliance.

  • Support change control, deviations, CAPAs and revision to documentation with direct or indirect impact on product release.

 

Requirements: 

  • Master Degree / Bachelor Degree in scientific field + 5 years’ experience in relevant industry or equivalent.

  • Experience in the pharmaceutical (small molecules or biotechnology) industry. Sound knowledge of cGMP requirements, EU/FDA regulations and compliance. Experience in clinical trials and/or regulatory is an asset.

 

If you are interested to learn more about this great opportunity, don’t hesitate to get in touch with me. Feel free to send me your CV at following email

 

olivier.worch@randstad.ch

I am looking forward to receiving your applications

 

Olivier Worch