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Attendeer FMF hierop
QC Senior Equipment Officer
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 site in Amsterdam, 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. Furthermore, the teams are responsible for Environmental Monitoring and Utility Monitoring, References and Consumables Management, the Stability Program and Management of the LIMS-system. As a QC Senior 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
Our client is looking for an experienced QC Senior Equipment Officer to support the QC Support Equipment Validation team in the introduction and (re)validation of new and existing laboratory equipment. You will perform assessments to select the required and preferred QC laboratory system and supplier. Based upon the analytical samples and test requirements, specifications, procedures and Pharmacopoeia monographs. You are also involved in the investment procedure in order to buy the new equipment and you will participate in the ICT intake meetings for computerised lab systems suppliers. Furthermore, as a Senior Equipment Officer, you will write and/or review the required validation documents (URS, Supplier assessments, Commissioning Protocol etc.). You will also write the system required documents, like system administration, system use, maintenance, calibration and job training procedures for the new systems. Furthermore you will write Periodic Review Reports of computerised laboratory systems. As a system Administrator you are responsible for Application User Management, User Reviews and Audit trail archiving/review. Besides, you will support and/or coordinate equipment related projects and related Trackwise changes. This position within a challenging and inspiring environment is full of variation and possibilities to extend your equipment validation skills and knowledge!
Het profiel / Your profile
• preferably a Bachelor degree with at least 5 years of experience in a Pharmaceutical laboratory and cGMP environment (QC or R&D)
• familiar with Pharmaceutical QC testing conform Pharmacopoeia monographs (Ph. Eur and USP)
• broad experience with writing and reviewing of QC equipment validation documents for both analytical, chemical and microbiological test equipment
• experience with Trackwise, Empower, Chromeleon, SAP, ICT procedures and LIMS
• good communication and negotiation skills to operate in multidisciplinary teams
• meticulous and sense of safety and hygiene
• stress resistant, flexible, independent, pro-active and hands-on mentality
• fluent in English both written and spoken
Het aanbod / The offer
• challenging position within an inspiring, inclusive and respectful working environment
• 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/20-039-FMF, to Tim van Loon: firstname.lastname@example.org.
For further information, please call Tim van Loon at number +31 (0)33 472 80 87.
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.