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QA Specialist Quality Systems

Posted 23 Mar 2024
Work experience
5 to 7 years
Full-time / part-time
Full-time
Degree level
Required language
English (Fluent)

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As QA Specialist – Quality Systems you support the deployment or management including training of Kite Pharma Quality Systems in a broad sense. The position allows breakdown into 3 main categories but the Specialist interfaces, as compliance partner, with many departments and internal and cross site stakeholders.

  • Joint maintenance, site system ownership and training of cross site procedures such as Change Control, Deviation and CAPA management and Internal Audit,
  • Continuous governance and management reporting of site compliance with the quality system's procedures
  • Identification of quality risks in activities and processes according to regulatory agency guidelines and Kite quality policies and procedures.

Kite, A Gilead Company

At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day – discoveries that include our own capabilities and our individual potential.

We’re currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.

Department Description

As QA Specialist Quality Systems you’ll be joining the Quality Systems team that covers, in addition to the below listed duties, training and document control disciplines, a small team in which people of all backgrounds and experiences are respected, and where working together focused on saving lives, by finding the cure for cancer, is a daily activity. You’ll be reporting to the Senior Management Quality Systems

Your Responsibilities

In this role, your responsibilities, among others, will be:

  • Ensuring, at site level or as a member of cross site quality system committees, Quality Systems conformance to regulations and quality policies,
  • Managing the Change Control system, deliver training (including administration) and act as (backup) chair of the Kite EU Change Control Review Board and other multidisciplinary teams associated with the subject,
  • Managing the Deviation and CAPA management systems, deliver training (including administration) and act as (backup) chair of the Kite EU Deviation Board,
  • Supporting coordination of multidisciplinary initiatives as part of Kite EU start up endeavors,
  • Supporting regulatory inspections and audits,
  • Ensuring proper maintenance and approval of cGMP documents,
  • Ensuring proper maintenance of the Kite Exception Management system,
  • Reviewing and approve proposed changes to systems and procedures,
  • Providing compliance guidance to product development projects and technical transfer activities, as required,
  • Tracking, reviewing, organizing and reporting metric and management information for use in continuous improvement and Quality Management Review.
  • Performing other duties as required.

Your Profile

The ideal candidate for this position can demonstrate

  • Strong knowledge of GMPs, pharmaceutical Law and legislation
  • Experience with Change Control, CAPA, Internal Audit, Deviations and other ICHQ10 quality systems
  • Strong knowledge of aseptic manufacturing processes.
  • Proficiency in MS Word, Excel, Power Point and exception management systems,

Education

  • Bachelor’s degree in technical discipline (Chemistry/Microbiology/Engineering or similar).

Knowledge/Experience

  • Required: Minimum of 5 years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product). Working knowledge of quality systems and regulatory requirements (EU GMPs and ICHQ10).
  • Preferred: ASQ, Black Belt/Green Belt certifications. Experience with ATMPs.

Personal skills

  • Strong written and verbal communication skills.
  • Ability to communicate and work independently with scientific/technical personnel.

For the past three decades, members of our team have been at the forefront of cancer immunotherapy. Today, we are a leader in engineered T cell therapy, changing the paradigm of cancer treatment with what is potentially the biggest breakthrough since the introduction of combination chemotherapy more than 60 years ago.

Pharmaceutical
Hoofddorp
2,000 employees