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Opis:

Qualified Person Nr ref.: /JOBS.pl An international Pharmaceutical company is looking for a QA specialist & QP to join a growing quality team in Cork.Position Summary:This position is responsible for carrying out tasks and projects related to management of Quality Assurance activities according to GMP.These activities include Material release, Change control, Event management, supplier qualification, Annual product review and validation compliance activities.Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met.Duties:Batch Record Review & material releaseEvent management systems including Review & Approval of Event, Deviations, and Customer complaints.Management of batch records design and approval. Ensures that Batch Operating Instructions are compliant with filed descriptions.Carries out tasks relating to the management of site change control systems.Supports all validation activities on site as described in the Site Validation Master Plan.Approves and compiles where appropriate validation protocols and reports(analytical, cleaning, computer, process, equipment, etc.).Supports system qualification and process validation activities.Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality AssuranceCo-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site.Participates in the introduction of new process or modified process steps, as part of a New Product Introduction Team (NPI)Perform GMP audits on-site and vendor facilities as requiredCarries out tasks related to the administration of site supplier approval process.Adheres to and supports the company safety policy and safety programmers.Engages in Site Credo initiativesPerforms QP certification of Sterile API batches (and related activities)Key Skills and Competencies required:Qualified Person (QP) qualification (does not have to be currently on a licence, but must be fully qualified)5 years QA or Validation experienceIf you are interested in making this your next career move, then send us an application. If you are interested to hear more about this opportunity or to see how we may be able to help you further we are looking forward to receiving your application. Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

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