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Associate QA

Eingestellt von Elevate Direct

Gesuchte Skills: Css

Projektbeschreibung

ASSOCIATE QA - LEIDEN, NETHERLANDS - €44 - €47 PER HOUR - 5 MONTHS

The department Quality Assurance sees to that quality systems are applied as per GMP standards within Janssen Biologics and is responsible for handling deviations, bulk (PFB/FB) and intermediate (DPC/CSS) release and change control. The QA department plays an important role in providing advice on quality topics to all departments, which are part of the supply chain. To fill in the opening due to a leaving colleague, we are looking for an enthusiastic and driven new colleague who can take up this challenging role as QA Associate.

SPECIFIC TASKS:

In the position as QA Associate you are the quality expert who, in cooperation with all supply chain departments, monitors and improves the quality of our production and quality systems in a constructive manner. You are therefore the first contact person for all departments with regards to quality issues and you work together with the respectively subject matter experts of these departments (Operations, QC, FEMA and RA).

* In case of deviations, you assess/review the outcome of the initial investigation and the proposed corrective actions. Furthermore you assess and oversee the quality of its related documentation.

* You are part of the deviation team investigation teams and monitor the quality of the Root Cause investigations. You assess potential consequences of deviations on the quality of our products. For specific deviations you also take the lead on the investigation yourself.

* You review and sign of investigation reports. Moreover you are responsible for the closure of deviation and CAPA records in Trackwise.

* You participate in (Global) escalations of issues, which have (potential) impact on the delivery of products to our patients.

* You participate in NPI (New Product Introduction), quality and capacity projects.

* You act as local quality owner, One Lab QA contact and you lead risk assessments.

* You are actively involved in initiatives that lead to higher quality and compliance awareness for the people on the shopfloor (Operations, QC, etc). You align and agree on improvement actions with the departmental subject matter expert and you follow up on the agreed solutions.

* Outside office hours you act as QA representative on a rotational basis with other colleagues and you can be reached by the pager or business mobile phone (24/7).

* You approve change notices (procedures) in name of QA.

JOB REQUIREMENTS:

*Academic and HBO (higher education) in biochemistry, biology or a pharmaceutical degree

* Relevant working experience in a GMP environment.

* You have a great sense for quality and excellent analytical abilities.

* You can make well motivated decisions on your own.

*Experience in data analytics, vaccines and New product introduction.

* You have an excellent proficiency in English both in word and in writing.

* Experience in methods such as Process Excellence, Co Think and Kepner-Tregoe is recommended.

ADDITIONAL INFORMATION ABOUT THE PROCESS

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services

If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.

Projektdetails

  • Einsatzort:

    Leiden, Niederlande

  • Projektbeginn:

    asap

  • Projektdauer:

    5 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Medien/Design

  • Skills:

    css

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