Position:
Location:
Salary:
Type:
Quality Assurance Specialist
Competitive
Permanent
My client, a leading Pharmaceutical organisation, specialising in ophthalmology, is seeking a QA Specialist to join their growing team.
Job’s mission
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- To ensure that operational quality-related tasks are performed in order to maintain operational licenses and Quality Management System (QMS)
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- To act as deputy of Responsible Pharmacist/(QP)
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- To perform the operational quality-related GDP tasks in NL and EMEA
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- To act as VQD and TrackWise key user and trainer in NL and EMEA
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Key activities & Accountabilities
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- to perform the operational tasks related to the usage / maintenance of WDA/MIA
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- to ensure that a quality management system is implemented and maintained
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- to ensure that initial and continuous training programs are implemented and maintained
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- to be the main point of contact between Netherlands and Oy (MAH) for products complaints handling
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- to ensure that relevant customer complaints in Holland, Belgium and Luxemburg are dealt with effectively
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- to handle and approve distribution deviations, investigations, CAPAs and changes together with SA and Oy QA
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- to ensure that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place
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- to support and conduct internal and external GDP/ GMP audits
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- to organize and document the Annual Quality Management Review together with the Netherlands Responsible Pharmacist
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