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About the company:

Our client is a leading  global biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care.

About the role:

As  Quality System specialist you support the deployment of Quality management Systems in a broad sense. You will maintain relationship with Specialist interfaces, compliance partner, internal and cross site stakeholder and work together to ensure the quality of products.

Responsibilities:

-Ensuring, , Quality Systems conformance to regulations and quality policies,
- Managing the Change Control system, deliver training (including administration) and act as (backup) chair of the  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 regulatory inspections and audits,
- Ensuring proper maintenance and approval of cGMP documents,
- Ensuring proper maintenance of the Exception Management system,

Requirements:

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

- Experience with Change Control, CAPA, Internal Audit, Deviations.
- Strong knowledge of aseptic manufacturing processes.
- Proficiency in MS Word, Excel, Power Point and exception management systems

Other info:

Interested? Please feel free to contact me for more information.