Job description
Yacht (Life Sciences) has a role of Quality Assurance Specialist at Johnson & Johnson Innovative Medicine in Leiden (the Netherlands).
QA Specialist will be part of QA Quality Systems team. In the current role of QA Specialist the job holder will performs its duties to coordinate and/or enable proper oversight, support and management of the Quality systems used by Johnson & Johnson Innovative Medicine.
QA Specialist will be responsible for proper execution of its job according to expectations as defined in GMP, Quality, Regulatory and J&J Compliance guides and regulations.
QA Specialist will independently perform standardized tasks in accordance with official procedures and processes. The focus is on managing and support of the J&J Quality systems (e.g. documentation, 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 onsite and off-site for long term preservation, and provides content of superseded and obsolete documents upon request.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 training
Competenties
Competencies
· Strong interpersonal skills
· Excellent written/oral communication skills in English
· Good organizational capabilities
· Flexible and accurate
Arbeidsvoorwaarden
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)
Bedrijfsinformatie
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.
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent.
contact
Anastassia Blechko
anastassia.blechko@yacht.nl
06-53941731
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