Pharming Group N.V.

Quality Engineering Specialist - Leiden

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Active since 09-04-2018 Job category Quality / Health / Environment ...
Location Leiden Level Professional
Educational level Bachelor / Graduate Employment type Fixed term contract with option...
Hours 40 Salary -

Pharming Group N.V. is committed to the development of innovative products for the treatment of unmet medical needs. We focus on the development and production of human therapeutic proteins to provide life-changing solutions to patients.


Quality Engineering Specialist

Based in: Leiden

Fulltime position

Department:

Pharming Group N.V. develops innovative protein therapeutics for the treatment of genetic disorders.

At this moment, the company is composed for further science, technology and new product develop-ment and commercial roll-out. The company is small (approx. 150 employees, based international) and entrepreneurial. The Quality Engineering Specialist must fit in this organizational culture where integrity, entrepreneurship and flexibility are core competencies.

Job description:

As part of the Quality Assurance (QA) team, you provide support on the efficient (c)GMP quality systems for Pharming's products. The quality systems apply to both internal procedures as well as systems at our contract-partners and suppliers. The necessary control functions are executed by review of documentation and by performing audits on (provider's) sites.

In addition, as the specialist on quality engineering and qualification, you have a leading role in the design, commissioning and qualification of Pharming's new entities, i.e. a new starting materials production site, new Quality Control laboratories and a high-tech biotechnological Downstream processing facility. In addition optimizations and optimizations of current facilities, both of Pharming and its contract manufacturing organizations (CMO's), should be accompanied and controlled.

After implementation, you remain responsible for verification of the continuous improvement activities, reconstructions and (periodic) requalification, including those of Pharming's CMO's.

You will provide technological input to all proposed changes and assist in the investigation and solution of issues when required, in a quality manner. This includes the technical support and interaction with the constructors of our (c)GMP quality facilities and utilities.

Note: although mainly based in Leiden, it will be necessary to perform tasks also at other locations in the Netherlands, in particular during prior to and following construction works.


Minimum qualifications:

Education:

Bachelor's degree in biotechnology, biopharmaceutical sciences, (bio)chemistry, engineering or alike.

Knowledge of quality systems (such as ISO 9001:2008), pharmaceutical Quality systems ((c)GxP) and in particular EU-GMP Annex 15 and US E2500-07 on Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment.

Two to three years of experience in (bio)pharmaceutical production, quality control or quality assurance and at least three years of experience with Quality Engineering projects.

Skills:

Analytical, accurate, pro-active, independent.

Effective communicator in conversation and writing, in Dutch and English.

Experienced with the use of MS-Office programs.

Apply:

Please apply via our website www.pharming.com or www.pharminggroup.heeft-vacatures.nl

attn. Ms. Gabriëlle Smit.

For all recruitment agencies: don't call us, we call you!

More information
This listing is a full-time job

Job category Quality / Health / Environment / Safety
Industry / Industries Medical / Health
Region Netherlands
Keywords

Contact information

Name nienke van der Veer

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