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Electronic System QA
Temporary position in Learning Management Systems for a pharmaceutical company
(Meppel, The Netherlands)
Het bedrijf / The company
Our client manufactures and markets high-quality drugs in a diversity of fields. The organisation has been undergoing substantial growth and expects to be a global top ten player. In Europe, our client produces, develops and markets products through a network of affiliated companies. The European R&D and manufacturing activities are concentrated in The Netherlands. The European organisation is located at Leiden but with a tight line to the other affiliates. In order to give extra support to a project the organisation is searching for an Electronic System QA.
De functie / The role
In this role you will be responsible for assisting Electronic Systems Quality Assurance in overseeing the computerized systems validation program. You will be an integral QA representative in numerous IT project teams. You will participate in working teams to provide direction regarding quality, validation and compliance. You will perform and coordinate the review and approval of validation deliverables including, but not limited to, computer system requirements, validation plans, test protocols, executed testing documentation, and validation reports. Working with systems means working with the IT staff to resolve issues identified during document reviews. You will assure compliance with corporate policies, SOPs, and regulatory agency standards (US, EU, and Japan, as needed). You will identify compliance issues and work with CSV QA staff to identify and implement corrective action as required. You will communicate compliance issues to ESQA management and schedule and perform assigned software vendor audits of newly identified or current, regulated and business critical software vendors. You will plan, conduct, and report results of assigned audits for an effectively and accurately document audit findings in audit reports and obtain responses in a timely fashion. Furthermore, you will assist with good manufacturing practice (GMP), good clinical practice (GCP), or good laboratory practice (GLP) audits of software vendors, software related service providers, clinical research organisations, related investigational research centers, and laboratories. You will assist as well as assess the adequacy and compliance of computer validation procedures and documentation at these facilities/sites. Last but not least you will assist in the evaluation of audit responses for compliance with applicable guidelines, regulations, and company policies. And you will obtain remediation when responses are unacceptable.
Het profiel / Your profile
• minimum B.A. / B.S. with at least 3-5 years’ experience in a Quality Assurance position (or similar) within a pharmaceutical environment or healthcare field. Experience in IT Compliance roles will be considered.
• experience in Computer System Development Life Cycle and Validation. Experience in Computer System Validation Quality Assurance / Software Quality Assurance is desirable.
• understanding of global regulatory requirements for electronic records and electronic signatures including but not limited to: CFR 21 Part 11, EU Annex 11, EU Directive 1999/93/EC, and Japan PFSB Notification No. 0401022.
• understanding of associated regulatory guidance documents.
• understanding of computer systems validation process, and process controls in the areas of GAMP 4 / GAMP 5, ISO 9000, ITIL, IEEE, and ASQ standards.
• GxP computerized auditing experience is required; Pharma, GMP, GCP, and GLP auditing experience is desirable.
• ability to represent the company to external stakeholders during vendor audits is required.
• effective written and oral communication and interpersonal skills, facilitation, and influencing skills with an ability to develop and maintain effective relationships across company groups and external stakeholders.
• capable of managing self and project teams across multiple assigned projects.
• ability to work 40 hours per week plus some overtime (approximately 8-12 hours overtime per week).
• ability to perform approximately 5-10% travel as needed for vendor audits. Travel will be primarily in the domestic region of resource’s primary office location (e.g. Europe, North America, or Japan). Occasional international travel is possible.
Het aanbod / The offer
• a specialised position in CSV for the pharmaceutical company
• interesting position to use your skills and knowledge
• temporary contract with the possibility to extend
Reactie / Reaction
Interested? Please send your resume and motivational letter by e-mail, with reference to DT/20-130-FMF, to Sandra van Putten: email@example.com. For further information, please call and discuss the opportunity with Sandra van Putten at number +31 (0)33 472 80 87.
An individual assessment may be part of the selection procedure.
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