QA Documentation Specialist

Posted 11 June 2021
salarisNegotiable depending on experience
LocatieHoofddorp, Haarlemmermeer, Noord-Holland
Job type Temporary
BedrijfssectorenScience, Kwaliteitscontrole / Veiligheid
referenceBBBH444077_1623443612

Job description


Quality System - Document Issuance Specialist

We are seeking a highly motivated individual to join us as a Quality Systems - Document Issuance Specialist reporting to the Quality Systems Document Control Senior Manager. You will work in Quality Assurance team in supporting our efforts in this exciting new area of cancer immunotherapy. You will be responsible from preparing the batch specific document package for manufacturing operations and as well as issuance of other controlled documents. You will work closely with Manufacturing Planning to ensure readiness of documents timely and right first time.

Responsibilities (include but are not limited to):
The Quality Systems Document Issuance Specialist will use Electronic Document Management System and enterprise resource planning (ERP) to issue controlled documents and labels. Working location is Hoofddorp.
Additional job duties include:
* Responsible for the management of all document issuance and archival processes to support GMP operations.
* Issue effective documents including procedures, test methods, specifications and batch documentation.
* Ensure accuracy and completeness of QA issued documents.
* Identify and escalate compliance gaps across the document management system
* Execute strategic initiatives to improve the document management system.
* Investigate deviations against the document management system and develop effective corrective action plans.
* Provide training to new staff on document management processes and procedures.
* Support audits (internal, external)
* Support projects as needed
* Perform other duties as required.

Hajar Amagir
T: 0626326600 or 023-7111190
When interested please react through the application process with your English resume.
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Met oog op de AWGB (Algemene Wet Gelijke Behandeling) verwelkomt Kelly Services sollicitaties van iedere geschikte kandidaat, ongeacht etniciteit, geslacht, beperking, religieuze overtuiging, seksuele geaardheid of leeftijd.

Met betrekking tot deze functie fungeert Kelly Services als uitzendorganisatie. Wanneer je de beslissing maakt om op deze functie te solliciteren zullen jouw gegevens in overeenstemming met Kelly's Privacy Statement worden verwerkt.

Met oog op de AWGB (Algemene Wet Gelijke Behandeling) verwelkomt Kelly Services sollicitaties van iedere geschikte kandidaat, ongeacht etniciteit, geslacht, beperking, religieuze overtuiging, seksuele geaardheid of leeftijd.

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Regarding this role, Kelly Services acts as the official temporary employment agency. When you decide to apply to this role your personal information will be processed in accordance with Kelly's Privacy Statement

In keeping with the AWGB (Algemene Wet Gelijke Behandeling) Kelly Services welcomes applications from any and all eligible candidates regardless of ethnicity, gender, disability, religion, sexual orientation or age.