Vacature Officer QA

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Officer QA

• Job Title Officer QA
• Function Quality
• Sub Function Quality Assurance
• Location Leiden, South Holland, Netherlands
• Date Posted Jan 24 2024
• Requisition Number 24W

Description

We are looking for an enthusiastic and motivated colleague who will help us to strengthen our QA team of Janssen Biologics, somebody who would like to contribute to a high-quality organization of the site and J&J. The main focus will be commercial product release but can vary over time.
The QA Officer acts as a quality expert and applies our Quality Systems to create, review and approve GMP documentation as needed for the commercial products at our manufacturing facilities. The QA Officer works in close collaboration with other departments (Operations (BU1 and BSWL), QC (BU4) and Global Planning.
The activities are very dynamic and varied. The candidate loves challenges, doesn't avoid problems, and enjoys working in various teams.
About the Company: Janssen Biologics B.V. 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. Janssen Biologics is part of the Johnson & Johnson family of companies. The department Quality Assurance sees to that quality systems are applied as per GMP standards within Janssen Biologics and is responsible for handling non-conformances, bulk (PFB / FB) and intermediate (DPC / CSS) release and change control. The QA department plays a significant 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 as QA Officer. The responsibilities & the impact YOU will have is:
• To prepare QP release documentation for raw materials, intermediate or (Pre) Formulated Bulk ((P)FB) in order to enable release decision on intermediate and final bulk products.
• To collect, prepare and review all relevant batch records and related documentation (e.g., QC test results, QC trending data, SAP tags and related change controls).
• Review and approve validation protocols and reports, change controls, validation assessments, URS and appliable lifecycle documentation;
• Track and monitor progress of changes to anticipate, flag and prevent any delays in change implementation;
• Review and approve routine GMP documentation for all components of the Quality system.
• Perform the Quality review of Periodic Review reports.
• Quality overview of the validated state of the utilities, equipment and processes.
• To supply to the preparation of Annual Reports, e.g. Site master File, APR, etc.
• To improve the process by, just doing it or using the A3process and participating in other inter departmental improvement initiatives;
• Participate in departmental automation or digital process improvement;
• Provide Site support for local or global projects as an extended core team member;
• To collaborate with QA and site colleagues;
• Act as a quality representative at routine site meetings and Quality on the floor activities.

We would love to hear from YOU, if you have the following essential requirements
• BSc in science related subject and /or business-related area with 2 years of experience;
• Msc in science related subject and/or business-related area with no experience;
• Affinity to electronic systems and data analysis is a pre;
• Problem solving and analytical capability - ability to prove trouble shooting expertise, through analysis and resolution of quality and compliance issues.
• Ability to manage diversity and conflicting viewpoints within production teams.
• Ability to drive collaboration in a fast-paced environment.
• Has a good communication to understand customer needs.
• You have demonstrated proficiency in English both in word and in writing.
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 ~2000 people who work here, or you're considering joining the team, we offer:
• Flexible working hours
• Your change to work in an organization that is a global market leader.
• A dynamic and inspiring working environment.
• Opportunities to work on exciting projects and assignments

：1-800-458-1653

Contact Information: 1-800-458-1653

Functie:	qa officer
Startdatum:	27-01-2024
Ervaring:	Ervaren
Educatielevel:	HBO
Contracttype:	Freelance
Salaris:	onbekend – onbekend
Uren per week:	1 – 40

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