Sr. Qualified Person Pharma

Baan gegevens

  • Bedrijf: Independent Recruiters
  • Plaats: Leiden
  • Plaatsingsdatum: 12-10-2021
  • Werkniveau: Universitair
  • Werkervaring: 5 - 10 jaar ervaring
  • Dienstverband: Vast contract


Algemene omschrijving

We are looking for an experienced Qualified Person for one of the leading global vaccine production companies based in Leiden.

Are you a registered QP with pharma experience and are you comfortable in both an R&D and commercial environment? Are you ready for a next challenge in a high end pharmaceutical R&D environment, like development of cell therapy and vaccines?

Please read along...

As a Qualified Person you are part of the Quality Assurance team which takes 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 a 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 new biological products and vaccines. These products will be used in Clinical Studies to prove their safety and efficiency prior to their commercialization. This is a quick evolving and dynamic environment. The team currently supports the manufacturing of a diverse range of vaccines (Drug Substance) and all related ongoing projects to increase capacity.

We are looking for a Qualified Person, with solid understanding of both cGMP guidelines and Quality Management systems. As EU-Qualified Person API, you ensure that (investigation) drug substances are manufactured, tested, labeled, packed, released, and distributed in compliance with cGMP guidelines and relevant regulatory authorizations. You will work in close collaboration with other departments (Operations, Lab, Engineering, Vaccines Launch Facility and Development Departments). In this position you report to the Sr Manager QA.

Your Responsibilities:

  • Release Drug Substance lots manufactured (for global distribution). This includes phase 1-3 clinical materials, process validation batches and batches for Emergency Use. This is also valid for intermediates shipped to other sites for further processing. You act as a backup QP for commercial products
  • Ensure safety, efficiency and quality of product released by JBV and to ensure compliance with 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
  • 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 recommendations 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

You will be offered a challenging job for a global leading company within pharmaceuticals.

Next to that you will be offered:

  • Salary between €70k and €100k on annual basis depending on experience and level
  • Annual Fixed Bonus
  • 38 holidays per year
  • Flexible working hours

Gestelde eisen

* Master's degree in Biochemistry, Biology, Pharmacy or another 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 plus * 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 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

Uren

32-40 hours

Salaris

set yearly bonus

Informatie over Independent Recruiters

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