Vacature Senior Associate QA/Qualified Person QP

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Senior Associate QA/Qualified Person (QP)

• Job Title Senior Associate QA/Qualified Person (QP)
• Function Quality
• Sub Function Quality Assurance
• Category Senior Analyst, Quality Assurance (P6)
• Location Leiden, South Holland, Netherlands
• Date Posted Jun 12 2024
• Requisition Number 24W

Description

We are looking for an enthusiastic and motivated colleague who will help us to strengthen our Quality Assurance team of Johnson and Johnson Innovative Medicine, somebody who would like to contribute to a high quality organization of the site and J&J.

The activities are very dynamic and varied. The candidate likes challenges, doesn't avoid problems and enjoys working in various teams.

About the Company: J&J Innovative Medicine 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, we continue to seek innovative ways to treat cancer, infectious diseases, cardiovascular and metabolic diseases, and immune-mediated inflammatory disorders (I.M.I.D.s), such as rheumatoid arthritis and psoriasis. 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.

To fill in this phenomenal new opportunity, we are looking for an enthusiastic and driven colleague who can take up this challenging role. The responsibilities & the impact YOU will have:

• Act as Qualified Person for Large Molecule products
• 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 complex site investigations and ensure that all CAPAs are implemented and effective within agreed timelines.
• Assist in the preparations and lead 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.g. but not limited to stability, validation.
• Act as member in Quality Risk Management and /or root cause investigation sessions.

Qualifications

Minimum education and experience required for the position:

We would love to hear from YOU, if you have the following essential requirements

• MSc in bioscience, chemistry, pharmacy or related subject
• Registered as Qualified Person
• 2-4 years Quality Assurance experience in pharmaceutical or related industry
• Good communicative, collaboration and advisory skills in English and preferably Dutch (verbal and written)
• Up to date knowledge of GMP regulations
• 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 subject areas and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers. Whether you're one of the ~1000 people who work here, or you're considering joining the team, we offer:

• Flexible working hours
• Your chance to work for a global market leader.
• A dynamic and inspiring working environment.
• Opportunities to work on exciting projects and assignments

Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

Except as specifically requested by J&J China or legally required, please avoid submitting information in your application which may be deemed as sensitive personal information, which includes biometrics, religious belief, specific identity, medical health, financial accounts, whereabouts, as well as information of minors under the age of fourteen (14), and other information that the breach or illegal use of which may easily lead to the infringement of an individual's personal dignity or harm to personal or property safety.

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The overseas recipient is Johnson & Johnson Services, Inc.,, which can be contacted at One Johnson & Johnson Plaza, New Brunswick, New Jersey 08933, U.S.

Processing Method: Conduct talent acquisition management through the unified process and globally connected applications, including storage, use, handling, transmission, and deletion of provided personal information. Overseas recipients will apply appropriate managerial and technical measures to ensure the confidentiality, integrity, and availability of the provided personal information and shall store such personal information to the minimum extent necessary to complete the above purposes.

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You may contact the Personal Information Protection Officer of the J&J China at to exercise your relevant rights to the overseas recipient, including access, correct, copy, or delete your personal information.

：1-800-458-1653

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Johnson & Johnson Services, Inc.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.

Functie:	associate qa/qualified person qp
Startdatum:	12-06-2024
Ervaring:	Ervaren
Educatielevel:	HBO
Contracttype:	Vast
Salaris:	onbekend – onbekend
Uren per week:	1 – 40

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