QA Specialist Documentation and Training management

Yacht
NL - Leiden
January 9, 2025
Medical

Bedrijfsomschrijving About the Company Johnson & Johnson is a multinational pharmaceutical company that has been for more than 25 years a leader in the field of biomedicines.
Through the dynamic science of biotechnology, they continue to seek innovative ways to treat cancer, infectious diseases, cardiovascular and metabolic diseases, and immune-mediated inflammatory disorders.
Why YACHT ? Because of challenging positions at leading (biotech) companies, a large network and development opportunities! These are the advantages of working via YACHT.
With us, you will get all the space to grow further.
Together we will look for assignments that suit your ambitions and help you to realize your goals.
Through coaching, for example, but also by inviting you to interesting courses, knowledge sessions and inspiring meetings.
Through us, you will get access to a network of professionals and companies that are happy to share their knowledge and opportunities with you.Functieomschrijving Job description Yacht (Life Sciences) is offering a position as a Quality Assurance (QA) Specialist at Johnson & Johnson Innovative Medicine in Leiden, the Netherlands.
As part of the QA Quality Systems team, the QA Specialist will coordinate and support the oversight, management, and proper functioning of the quality systems utilized by Johnson & Johnson Innovative Medicine.
This role requires adherence to Good Manufacturing Practices (GMP) and compliance with quality, regulatory, and Johnson & Johnson's internal standards and guidelines.
The QA Specialist will perform standardized tasks independently, following established procedures and processes, with a primary focus on managing and supporting J&J's quality systems, including documentation and training systems.
Key Responsibilities:
Documentation Management:
Acts as TruVault SME for system training, support and administration.
Reviews as SME documents for compliance with GMP regulations; guidance, company standards and other SOPs for impact on patient safety and product quality.
Acts as SME for internal and external archiving.
Manages issuance and archival of quality records like test records, external reports, logbooks etc.
onsite and off-site for long term preservation, and provides content of superseded and obsolete documents upon request.
Training Management Maintains the Learning Management System (LMS) in support of the operational departments.
Acts as first point of contact for training for the PDQ department and Departmental Training Delegates (DTD).
Organizes JVL Site based training, including maintenance of a matrix and coordinates the local training related procedures and ensures yearly training record review for department.
Supports Department Manager regarding training related responsibilities.
General Quality Systems support Can act as Superuser for TruVault and other relevant J&J Quality systems.
Issuance of Initials to be used on company documents.Functie-eisen Job requirements Bachelor's degree in a life science study or equivalent experience 1-3 years of experience in a pharmaceutical environment Preferably familiar with GMP Experienced in providing trainingArbeidsvoorwaarden Terms of employment We offer a competitive employment package in line with the seniority of the position, with a salary between €2,800 and €3,950 per 4 weeks/based on 40 hours per week.
You will always be paid 100% of your salary during your employment contract.
This concerns a contract via Yacht with an initial assignment for 6 months at Johnson & Johnson, with a possibility of extension.
Working full-time, 40 hours p/w is preferred (32-36 h p/w can be discussed)

Read the full job description and apply online on the recuiter's web-site

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