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Validation Specialist (Bioprocessing)

Apply Now Job ID R0004454 Date posted 09/18/2018 Location:Dublin, Ireland

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Job Description

JOB PURPOSE:

The Validation Specialist (Bioprocessing) is responsible for the coordination of validation activities principally related to Alofisel® (Advanced Therapeutic Medicinal Product) and ensuring compliance with current regulatory requirements.  The Validation Specialist (Bioprocessing) will have specific and varying duties as assigned by the Quality Systems and Compliance Manager.  Some key tasks and responsibilities are outlined below.

RESPONSIBILITIES:

  • Provide validation expertise in the Alofisel® Production area ensuring compliance with current industry regulations, guidelines and trends.
  • Coordinate execution of validation activities including the following:
  • Qualification of premises, equipment and utilities.
  • Including aseptic processing systems oversight (media fill, VHP validation, Environmental Monitoring)
  • Computer system qualification.
  • Laboratory equipment validation.
  • Process validation.
  • Cleaning validation.
  • Participate in cross functional project teams and assist in determining project schedules and appropriate levels of validation.
  • Provide validation position on related topics and strategy and prioritise qualification activities in line with the project schedules.
  • Responsible for preparation, review and approval of validation protocols, reports, procedures, deviations, change controls and other related documents to ensure compliance to internal procedures and regulatory requirements.
  • Act as a subject matter expert in process validation which will be performed against global corporate SOP/HPRA /FDA/EMEA requirements.
  • Execute and document process risk assessment / failure mode and effects analysis.
  • Ensure GMP compliance for validation deliverables related to site and capital projects (Compliance, Improvement, Technology Transfers, etc.) including requirements definition, specification, qualification, process validation and change management.
  • Provide validation expertise and support for the development (or modification phases) of manufacturing facility, equipment/systems, Material Qualification, Process Validation and Automated System and Computerized System.
  • Approve and support the definition of the process development strategies and ensure linkage with PPQ strategy deployment.
  • Provide support during internal and agency inspections, Annual Product Quality Review and performing quality assessment for engineering changes.
  • Prepare and maintain Validation Master Plans.
  • Participate in other projects as directed by the Quality Systems & Compliance Manager.

GENERAL RESPONSIBILITIES:

  • Participate fully in any cross functional training initiatives.
  • Drive and promote the corporate values of Takeda-ism within the workplace.
  • Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business.
  • Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.
  • Ensure timely completion of all SOP, reading, training and assessment.
  • Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.

EDUCATIONAL REQUIREMENTS:  

  • Primary degree is scientific discipline, preferably Biotechnology or Engineering.

RELEVANT EXPERIENCE:

  • A minimum of 7 years working within quality in the pharmaceutical industry.
  • A minimum of 4 years validation experience.
  • Experience of sterile manufacture is essential.
  • Experience of biologics manufacture is desirable.
  • Experience working with ATMP is desirable.

SKILLS/COMPETENCIES:

  • Knowledge of Good Manufacturing Practice for Advanced Therapeutic Medical Product (ATMP).
  • Excellent verbal and written communication skills
  • Be self-motivated, flexible, organised and a good team player with the ability to prioritise own work based on departmental and site requirements

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