Johnson & Johnson
Quality Assurance
Quality Assurance
Location: Leiden
Duration: 12 months contract
Hours: 40h
Remote way of working
Imagine your next role as a Quality Assurance Specialist where you will be responsible for providing support to the account manager through review of batch and validation documentation, assessment of deviation investigation, CAPAs and change requests, completion of release packages, and management of routine issues to ensure the highest levels of quality and compliance for Janssen Biologics products.
Responsibilities
Interact with Internal Quality Assurance Managers and External Manufactures to perform batch record reviews and complete release packages for global markets.
Evaluate batch manufacturing records, deviations, and associated CAPA plans, and identify issues that may impact the quality of the product or compliance with marketing authorizations.
Independently resolve minor issues.
Consult the account manager as needed for resolution of major issues.
Ensure that all relevant QA-related concerns at external manufacturing sites are raised to Janssen management.
Ensure Janssen-specific manufacturing operations at external manufacturing sites are executed in a compliant manner.
Proactively identify risks and potential issues and delays in market release, and where possible, drive resolution
To be successful in this role you have:
Knowledge of the requirements for the production and release of Biologics products in the EU and associated countries, and in-depth knowledge of deviation management processes.
A minimum of 5 years working in an FDA or similar regulated environment; Quality Assurance experience preferred.
A minimum of 3 years of experience working with pharmaceutical GMPs, specifically biopharmaceutical experience is preferred (QA and/or production).
Strong interpersonal and English written/oral communication skills.
Proficient in applying process excellence tools and methodologies.
Able to build connections with stakeholders, team workers and manage across cultures.
benefits
This role offers a very competitive hourly rate & a supportive working environment. This contract will run initially for 12 months. This role requires traveling to Denmark about twice per year.
you are welcome here
Janssen is an innovative pharmaceutical company: we work every day on the frontline of health innovation. We can only meet this challenge because of our talented employees. Working at Janssen means that you get every opportunity to optimally develop your career.
about Janssen
Janssen is the Pharmaceutical Company of Johnson & Johnson - the world's most comprehensive and broadly-based healthcare Company. At Janssen, we bring together top scientists and researchers to pursue the most promising science and drive collaboration to create visionary medicines and healthcare solutions covering five priority therapeutic areas - Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, and Oncology. Contribute to the next pharmaceutical breakthrough with your next project at Janssen.
https://www.janssen.com/netherlands/nl/janssen-nederland/biologics-leiden
application process
We are looking to process the first round of applications within the next 2 working days.
We do not accept applications via email.
Diversity, Equity & Inclusion
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.
That is why we in the Netherlands are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.
Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!