Pharming Group N.V.

Qualified Person - Leiden

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Active since 05-02-2018 Job category Quality / Health / Environment ...
Location Leiden Level Professional
Educational level Master / Post-Graduate / ... Employment type Fixed term contract with option...
Hours 40 Salary -

Function:

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

The company is mid-sized (approx. 150 employees, based international) and entrepreneurial. The Qualified Person (QP) must fit in this organizational culture where integrity, entrepreneurship, flexibility and stress-resistance are core competencies.

As (second) QP you will become the direct deputy of Pharming's (first) QP but you are also an essential part of the QA team. This function requires that, depending on the relevant experience of the candidate, a substantial period is foreseen for execution of all QA Officer tasks and personal training by the current QP, before the application for QP will be submitted. In time, the candidate will also be the manager of a small group of QA officers dealing with manufacturing, testing and release of Pharming's products.

Job description:

As part of the QA team of Pharming, you make a contribution to the implementation of and maintaining an efficient (c)GMP quality system for Pharming's biotechnological products. The quality systems apply to both internal procedures as well as systems at our contract-partners. The necessary control functions are executed by review of documentation and by performing audits on (supplier's) sites.

As Second QP, you will become responsible for the legally authorized pharmaceutical release of starting materials, drug substance, drug product and final product manufactured by or under the responsibility of Pharming for commercial use or use in clinical trials.

Tasks & responsibilities:

Implementation, execution and maintaining document- and change-control, deviation- and inspection-management and training. Review of batch records, logbooks, scientific reports, policies and procedures. Release of intermediate and final products. Auditing contract-partners and service-providers. Writing procedures, audit reports and periodic quality oversight reports. Managing a small group of QA officers.



Minimum qualifications:


Education and experience:

University degree pharmacy and pharmacist, preferably BIG-registered. Knowledge of GMP, GDP, GLP, GVP and other Quality systems (ISO 9001:2008). Minimum five years of relevant experience with biotechnological production processes, (bio)pharmaceutical R&D, quality control and/or quality assurance. Minimum three years of experience as manager and as auditor of suppliers or contract-partners; preferably also experience with inspections by the authorities (IG, FDA).


Skills:

Analytical, accurate, pro-active, independent, stress-resistant. Managerial skills, 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.

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More information
This listing is a full-time job

Job category Quality / Health / Environment / Safety
Industry / Industries Medical / Health
Region Zuid-Holland
Keywords

Contact information

Name nienke van der Veer

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