QUALITY ASSURANCE SPECIALIST

This position will be based at our Leiden site.
Initially a 12-month fixed-term contract, with the intention to extend.
Change lives for the better.
At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at https://www.
nj.
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THE OPPORTUNITY The department Quality Assurance ensures that quality systems are applied as per GMP standards within J&J Innovative Medicine and is responsible for handling non-conformances, bulk product and intermediate product release and change control.
The QA department plays an important role in providing advice on quality topics to all departments of the supply chain.
The QA associate will be the linking pin in the investigations into Non-Conformances and with that responsible for the improvement of the overall quality status.
The activities are very dynamic and varied.
The candidate likes challenges, doesn’t avoid problems and enjoys working in various teams.
To fill in this phenomenal new opportunity, we are looking for an enthusiastic and driven colleague who can take up this challenging role as QA Associate.
The responsibilities & impact YOU will have.
Ensure that in a timely manner a clear and quality prospected advice is given to all cGMP and/or quality related issues encountered during (non)routine operations.
Lead all aspects of site investigations and ensure that all CAPAs are implemented and effective within agreed timelines.
Assist in the preparations for and during inspections (FDA, EMA etc.) to accomplish a successful audit.
Perform level assessment, review and approval of (deviation related) change controls.
Partner with site colleagues to ensure all site changes and projects are conducted in a compliance to cGMP and company quality requirements.
Assess, review and approve study protocols and reports to assure that studies will be executed in a controlled and systematic manner conform cGMP and regulatory requirements e.
.
but not limited to stability, validation.
Act as member in Quality Risk Management and /or root cause investigation sessions.
Qualifications We would love to hear from YOU, if you have the following essential requirements.
To be successful, you demonstrate the ability to communicate effectively at all levels within a virtual matrix environment.
Further requirements include.
BSc in bioscience, chemistry, pharmacy or related subject with 4-6 years of experience.
MSc in bioscience, chemistry, pharmacy or related subject with 2-4 years of experience.
Good communicative, collaboration and advisory skills in both Dutch and English, both (verbal and written) Up to date knowledge of GMP regulations Preferably Quality Assurance experience in pharmaceutical or related industry Experience with quality investigations, root cause problem solving and quality risk management Familiarity with PE, LEAN tools, concepts and methodologies is preferable.
This is what awaits YOU at J&J This is an opportunity to work with a highly motivated team and to be a member of a Johnson & Johnson company, with an excellent record in employee continuous professional development and business improvement.
We are passionate about our work; we play vital roles across a range of professional disciplines and care deeply about our customers and communities.
At Johnson & Johnson our culture enables dynamic and impactful careers.
Whether you’re one of the ~ people who work here, or you’re considering joining the team, we offer.
Flexible working hours.
An opportunity to be part of a global market leader.
A dynamic and inspiring working environment, including operating globally.
Opportunities to work on challenging projects and assignments.
Possibilities for further personal and professional development/education.
Excellent Benefits.
Closing date.
Friday, 18th of October .
Being part of Johnson & Johnson can change everything, including YOU 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 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”!