Our client, who is an international pharmaceutical, is looking for a QA Documentation Specialist 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.
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 Kite's Electronic Document Management System and enterprise resource planning (ERP) to issue controlled documents and labels.
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.
· Scan and store the documents to defined electronical repository.
· Peer review completeness of scanned documents.
· Archive the scanned documents.
· Support re-structuring of archiving system when needed.
· Data transfer between hard and soft copy records, when needed.
· Support transfer of documents between facilities, if needed.
· Work with off-site archive and organize documents transfers, if needed.
· Experienced document archiving specialist with GMP knowledge
· 2+ years of relevant document archiving experience in a regulated area
· Demonstrates strong working knowledge of Document archiving.
· Demonstrates strong verbal, written, and interpersonal communication skills in English.
· Demonstrates proficiency in Microsoft Office applications.
· Detail oriented, methodical and logical
· Organized, with excellent administrative skills
· Able to work in a team
· Excellent verbal communicators
· Comfortable in a fast-paced environment with minimal direction.
What do we offer
· Temporary agency contract via Kelly Services
· Start date: ASAP; 12 months project with possible extension or conversion contract client
· Salary indication depending on experience
Please do contact Marcella Henryati, Recruitment Consultant
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.