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QC Equipment Officer

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Introductie

Challenging position within an inspiring, inclusive and respectful working environment

Het bedrijf / The company

The organisation produces and exports a broad range of pharmaceuticals for patients throughout the world. At their production sites in Amsterdam and Brussels, they prepare a broad range of medicines derived from blood plasma. These products are used for a large number of disorders, many of which life-threatening.
This position will be part of the QC Support team which is one of the two QC departments within the organisation. These teams support QC operations with validation, maintenance and calibration of equipment, validation of analytical and microbiological methods and coordination of QC support in different projects. Also, these teams are responsible for all QC related changes, quality agreements and external contact management. As a QC Equipment Officer you will be part of a motivated team of equipment and method validation specialists where you can work on your personal development, ambitions and personal choices.


De functie / The role

In this position you will perform assessments to select the required and preferred QC laboratory system and supplier based upon the analytical samples and test requirements, specifications, SPP procedures and Pharmacopoia monographs. In addition, you are involved in the SPP investment procedures in order to buy new equipment. You will also participate in the ICT intake meetings for computerized lab systems suppliers. In this role, it is also your responsibility to write, or review, the required validation documents, the system required documents and Periodic Review Reports of computerized labsystems. As a QC Equipment Officer you are responsible for application User Management, User Reviews and Audit trail archiving/review. Finally, you will support and/or coordinate equipment related projects and related Trackwise change.


Het profiel / Your profile

• preferably a bachelor with at least 5 years of experience in a Pharmaceutical laboratory and cGMP environment
• familiar with pharmaceutical QC testing
• broad experience with writing and reviewing of QC equipment validation documents
• broad experience with equipment validation guidelines and rules
• experience with Trackwise, Empower, Chromeleon, SAP, ICT procedures and LIMS;
• good communication and negotiation skills to operate in multidisciplinary teams
• stress resistant, flexible, independent, meticulous pro-active and hands-on mentality
• fluent in English both written and spoken


Het aanbod / The offer

• part of a motivated team of equipment and method validation specialists
• working on your personal development, ambitions and personal choices
• position full of variation and possibilities to extend your equipment validation skills and knowledge


Reactie / Reaction

Interested? Please send your resume and motivational letter by e-mail, with reference to WL/20-055-DD, to Tim van Loon: info@derksenderks.nl.
For further information, please call Tim van Loon at number +31 (0)33 472 80 87.

An individual assessment may be part of the selection procedure.


Tenslotte ..... / Finally ....

Our client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.


Solliciteer hier
Indien solliciteer hier u verwijst naar een ongeldig webadres, is de vacature (hoogstwaarschijnlijk) inmiddels vervuld. Attendeer FMF hierop

Uw referentie aan www.fmfvacatures.nl wordt gewaardeerd.
Your referral to www.fmfvacatures.nl is appreciated.


Gegevens

Werkgever:
Derks & Derks
Vacaturesteller:
Derks & Derks
Standplaats:
Amsterdam

Geplaatst op FMF: 08 mei 2020

Branche: Farma & Biotech
Functie: QC / Laboratory
Opleidingsniveau: HBO / BSc, WO/academisch / MSc, PhD
Werkervaring: 5-10 jaar, > 10 jaar