Quality Systems Archive Specialist (QA Documentation)

Posted 16 December 2021
Salary€300 - €3400 per month + Negotiable depending on experience
Job type Temporary
DisciplineHealthcareLife sciences careers

Our client, who is an international pharmaceutical, is looking for a Quality Systems Archive Specialist (QA Documentation Associate) (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:
The Quality Systems Archive Specialist (QA Associate) will use our client's Electronic Document Management System and enterprise resource planning (ERP) to issue controlled documents and labels.
* 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.

* 2+ years of relevant experience in a GMP environment related field
* Completed MBO+/HBO studies preferably in a pharmaceutical or scientific discipline
* Working knowledge of electronic documentation systems, data retrieval, and electronic file formats.
* Detail oriented with solid problem-solving acumen.
* Ability to work effectively in a team environment.
* Demonstrates critical thinking, problem-solving skills
* Experience generating metrics preferred.
* Proficient in MS Word, Excel, and Power Point
* Demonstrates good interpersonal, verbal and written communication skills, which are essential in this collaborative work environment.
* Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
* English required and Dutch a plus

What do we offer
· Temporary agency contract via Kelly Services for 6 months
· Start date: ASAP
· Salary indication depending on experience: € 3000-€ 3400 gross per month based on 40 hours

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.