QA Documentation Specialist

Posted 02 September 2022
Salary Up to €4153 per month + Negotiable depending on experience
LocationHoofddorp
Job type Temporary
DisciplineHealthcareLife Sciences Careers
ReferenceBBBH556808_1662150771

Job Description


Our client is a biopharmaceutical company engaged in the development of innovative cancer immunotherapy and they are immediately looking for a QA Documentation Specialist (shifts, Monday-Sunday 8:00-16:30, 40 hours) in Hoofddorp.

All applicants MUST have full legal authorization to work in the EU region independently and be fluent in both spoken and written English language.

Key responsibilities:
§ Maintain a document management system compliant with regulatory, quality and Kite requirements.
§ Manage and maintain the archival of documents and records such that required documentation is retrievable and files are accurate, complete and well organized.
§ Provide guidance and advice on approved procedures, standardization and requirements associated with the document management system.
§ Working knowledge of quality systems requirements.
§ Support tracking and communication of site metrics to management.
§ Identify and escalate compliance GAPS across the archive system
§ Provide support for audits and regulatory agency inspections.
* Provide general support for the overall Quality System.
Requirements

 Demonstrates ability to prioritize and meet deadlines.
 Demonstrates attention to detail and ability to consistently deliver accurate output in routine accountabilities.
 Demonstrates an ability to effectively communicate with peers.
 2+ years' of experience on document management in a regulated environment.
 Advanced level of English communication.
Demonstrates advanced technical knowledge GMP
 Demonstrates the ability to clearly and concisely present/ explain document issuance operation and its requirements /guidelines to multiple internal audiences.
 Demonstrates ability to cross train colleagues and customers..
 Demonstrates an ability to communicate effectively with stakeholders, senior colleagues and peers
 Demonstrates the ability to think outside of the process and consider the impact decisions will have on other areas.

What do we offer
§Temporary agency contract via Kelly for 12 months with possible extension or conversion client contract.
§ Start date: 1 October 2022 / End date: 30 September 2023
§ Salary: € 4.153,- gross per month based on 40 hours excluding shift allowance 1,99%; excluding travel allowance by OV or € 0,19 per km to a max. of 100KM per day and up to a maximum of € 338,- per month.

Enquiries
Please do contact Marcella Henryati, Recruitment Consultant
M: 06-58811958
When interested please apply with your English resume on our website: www.kellyservices.nl

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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.