Pharming Group N.V.

Qualified Person - Leiden

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Active since 05-02-2018 Job category Quality / Health / Environment ...
Location Leiden Level Mid-Senior level
Educational level Master / Post-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.


Qualified Person and Manager QA Operations


Based in: Leiden

Fulltime position

Function:
Pharming Group N.V. develops innovative protein therapeutics for the treatment of genetic disorders.
The company is mid-sized (approx. 155 employees, based international) and entrepreneurial. The Manager QA Operations and Qualified Person (QP) must fit in this organizational culture where integrity, entrepreneurship, flexibility and stress-resistance are core competencies.

As Manager you will be responsible for that group of QA officers who deal with manufacturing, testing and release of Pharming's products. As QP you will also be responsible for the thorough evaluation and release to market of Pharming's products. This function requires that with a fair chance the application for QP will be approved by IGJ/Farmatec.

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 generating appropriate Quality agreements, by review of manufacturing and testing documentation and by performing audits on (supplier's) sites.
As 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 the QA Operations department and release of Pharming's intermediate and end products.

Minimum qualifications:
Education and experience:
University degree pharmacy and pharmacist, 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 authorities (IGJ, 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

Location

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