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Associate QA



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Introductie

The department Quality Assurance sees to that quality systems are applied as per GMP standards within Janssen Biologics and is responsible for handling non-conformances, 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. If you would like to know the company better, then this a great opportunity!

Het bedrijf / The company

Janssen Biologics

Extra info

Primary Location
Netherlands-South Holland-Leiden-
Organization
Janssen Biologics (7266)
Job Function
Quality Assurance
Requisition ID
1805699913W

De functie / The role

(Jr) Associate QA

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, One Lab, FEMA and RA). The QA department has a commercial and NPD/NPI branch. This position will be placed for now within the NPI branch.

In case of non-conformances, you assess/review the outcome of the initial investigation and the proposed corrections. Furthermore you assess and oversee the quality of its related documentation.
You are part of the investigation teams and monitor the quality of the Root Cause investigations. You assess potential consequences of non-conformances on the quality of our products.
You review and sign of investigation related reports. Moreover you are responsible for the closure of the Quality Investigations and CPA 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 risk assessments as applicable.
You are actively involved in initiatives that lead to higher quality and compliance awareness for the people on the shopfloor (Operations, One Lab, 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 roulation 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 and handle change controls in relation to CPA actions.
You participate in NPI (New Product Introduction), quality and capacity projects.



Het profiel / Your profile

Academic and HBO (higher education) in biochemistry, biology or a pharmaceutical degree, and depending on education, 5 to 7 years relevant working experience in a GMP environment.

You can make well motivated decisions on your own.
You have a great sense for quality and excellent analytical abilities.
Experience in data analytics, vaccines and New product introduction is a pre.
You have an excellent proficiency in English both in word and in writing.
You have strong oral and written communication skills
Experience in methods such as Process Excellence, Co Think or Kepner-Tregoe is recommended.


Solliciteer hier
Indien solliciteer hier u verwijst naar een ongeldig webadres, is de vacature (hoogstwaarschijnlijk) inmiddels vervuld. Attendeer FMF hierop

Uw referentie aan www.fmfvacatures.nl wordt gewaardeerd.
Your referral to www.fmfvacatures.nl is appreciated.


Gegevens

Werkgever:
Janssen Biologics
Vacaturesteller:
Johnson & Johnson
Standplaats:
Leiden

Geplaatst op FMF: 08 januari 2019

Branche: Farma & Biotech
Functie: QA / regulatory
Opleidingsniveau: HBO / BSc
Werkervaring: 0-2 jaar, 2-5 jaar, 5-10 jaar, > 10 jaar