Johnson & Johnson

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QA Associate

Job Description

QA Associate (New Products Development & Launch)

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 in Leiden is currently manufacturing COVID 19 vaccine (Drug Substance) vaccine. Janssen Biologics is part of the Johnson & Johnson family of companies.

The Department: As Quality Assurance we take a stand to consistently ensure the delivery of safe, cost effective and high-quality products for the patients in need. The QA department has a commercial and an NPD (New Product Development) & Launch branch. This position will be placed within the NPD & Launch group. QA NPD & Launch provides end-to-end Quality support (i.e. non-conformance management, CAPA, change control, validation and batch disposition) for our new biological products and vaccines. These products will be used in Clinical Studies to prove their safety and efficacy prior to their commercialization. This is a quick evolving and dynamic environment. Our team currently supports the manufacturing of COVID 19 vaccine (Drug Substance) vaccine and all related ongoing projects to increase capacity.

The Position: At QA NPD & Launch, we are currently looking for a QA Associate, with strong knowledge of both cGMP guidelines and Quality Management systems, to join our team. As an enthusiastic QA Associate NPD & Launch with a strong sense of urgency and a passionate commitment to getting things done, you will be the primary point of contact for all New Products quality related topics within the Leiden manufacturing site (i.e. development departments, production facilities and quality control labs). You will provide independent reviews and ensure that a clear, pragmatic and quality driven advice is given regarding the state of GMP compliance. The QA Associate works in close collaboration with other departments (Operations, One Lab, Engineering, Vaccines Launch Facility and Development Departments). In this position you report to Sr Manager QA NPD & Launch and will work together with QA officers and QA Associates.

Day to Day Responsibilities:

  • Participates as Core Team Member in New Product Introduction projects
  • Provides Quality oversight to the introduction of New Products (Biologicals and / or Vaccines) to the site
  • Assesses, reviews, and approves 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, analytical technical transfer
  • Assesses the Quality Issues for possible impact on product quality, process or compliance status and makes recommendation on product disposition (e.g., Harvest, Intermediates, (P)FB or Drug Substances). Reviews/approves the outcome of Quality Investigations, provides support to investigation teams, and monitors the quality of the Assignable or Root Cause investigations.
  • Provides Quality support for the development of appropriate Corrective and Preventative actions and provides Quality approval
  • Partners with site colleagues to ensure all site changes (e.g., to production processes, equipment, and systems) are conducted in a controlled and systematic manner and conform to cGMP and other regulatory requirements.
  • Participates in risk assessments to ensure compliance or quality is not jeopardized
  • On a rotation basis is available 24/7 as QA representative for Quality issues
Qualifications
Job requirements:
  • Bachelor’s degree or higher in Biochemistry, Biology, Pharmaceutical degree or relevant education.
  • Ability to drive collaboration in a fast-paced environment
  • Good negotiation / influence skills with customer-centered attitude
  • Depending on education, BSc 6 years and for MSc 4 years of experience in a GMP regulated environment (manufacturing, QA and/or QC)
  • Knowledge and Experience in vaccines is a pre
  • Excellent analytical abilities, eye for details
  • Empowered professional who can make well motivated pragmatic decisions on their own.
  • You have an excellent proficiency in English both in word and in writing. Dutch is an advantage.
  • Experience in methods such as Process Excellence, Co Think or Kepner-Tregoe is recommended.
Preferred knowledge & Experience:
  • Proven knowledge of the biotechnological/pharmaceutical industry
  • Trackwise, SAP systems
  • Experience in data analytics and data visualization
  • Proficiency in Lean or Six Sigma
Primary Location
Netherlands-South Holland-Leiden-
Organization
Janssen Biologics (7266)
Job Function
Quality
Requisition ID
2105962952W
Type vacature:
Intern

Vaardigheden

  • Er is geen minimale opleiding vereist