Johnson & Johnson

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Originele vacaturetekst

Senior Associate and Qualified Person

Job Description

Sr QA Associate / Qualified Person

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 Sr QA Associate / Qualified Person, with solid understanding of both cGMP guidelines and Quality Management systems, to join our team. As EU-Qualified Person API, you ensure that (investigational) drug substances are manufactured, tested, labeled, packed, released, and distributed in compliance with CGMP, J&J Guidelines and relevant regulatory authorizations. You will work 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.

Day to Day Responsibilities:

As Qualified Person:

  • Releases Drug Substance lots manufactured (for global distribution). This includes phase 1-3 clinical materials, process validation batches and batches for Emergency Use (e.g. COVID-19 vaccine). This is also valid for intermediates shipped to other sites for further processing. You act as a backup QP for commercial products.
  • Ensure safety, efficacy and quality of product released by JBV and to ensure compliance with J&J policies, worldwide health regulations and cGMP
  • Approval of High Risk (Global) Change Controls. Represent site in the local change control board.
  • Acts as member of the Site CAPA Board
  • Lead Quality escalations and communication of complex issues
  • Acts as the Qualified Person and SME at the JBV site during inspections by Health Authorities
  • Partner in the Executive Management Review
  • Reviews and approves critical quality documents
  • Represents QA in Global projects
  • Acts as Deputy of (Sr) Manager QA NPD as required

As Sr QA Associate:

  • 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 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
  • 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:

  • Master’s degree 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
  • Proven knowledge of the biotechnological/pharmaceutical industry and at least 6 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 and Dutch both in word and in writing.
  • Experience in methods such as Process Excellence, Co Think or Kepner-Tregoe is recommended.

Preferred knowledge:

  • 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
2105953181W
Type vacature:
Intern

Vaardigheden

  • Er is geen minimale opleiding vereist