Risk & Investigation Lead

Competitive
Permanent
Dublin
23 Apr 2019
BBBH727518

Experienced Process Scientist required for leading biotech.

This leading biotech facility are recruiting an experienced Risk and Investigations Lead. This is a permanent role.

You will be working with the Manufacturing Science & Technology Team at their state of the art, single-use multi-product biotech facility.

Responsibilities

  • Stay actively involved by participating in inspections, GEMBAs and reporting safety observations.
  • Challenge and identify improvements to the safety and environmental programmes on site.
  • Manage risk assessment processes for how risk is identified, assessed and mitigated across the site.
  • Develop the risk management plan with key stakeholders, using the supporting governance to reduce the overall risk profile at Biologics.
  • Own the risk management control process through visual management, this includes the development and completion of actions in response to performance trends, program reviews, inspections and industry expectations.
  • Set the standard for site investigations based on an enterprise organisational model approach, including technical writing for all SDWTs and Hubs
  • Demonstrate deep understanding of the investigative methodologies
  • Own the daily triage meeting with the Quality Systems Hub
  • Manage and assign investigation resources across the site, providing developmental opportunities across the value stream
  • Own the Investigation Review Board (IRB) for major and critical investigations, providing technical input, coaching and support in preparing lead investigators for the IRB.
  • Provide oversight of the CAPA effectiveness process with the Quality Systems Hub
  • Develop and maintain meaningful KPIs for risk management, investigations and CAPAs.
  • Provide technical advice / input across the wider Manufacturing Science and Technology Hub to support commercial manufacturing.
  • Participate in the New Product Introduction Teams, for risk assessments and in defining appropriate control strategies with scientists, engineers and self-directed working teams.
  • Create an environment of right first timein everything that we do through a focus on principles of lean, including simplification, standard work, visual management and a learning organization.

Education and Experience Requirements

  • Level 8 Degree or Masters in Chem. Eng, BSc. / Ph.D. in Biochemistry, Biotechnology or related scientific discipline
  • Experience of leading Investigations within the Biopharmaceutical Industry is required.
  • Leadership in risk management processes and methodologies is desired
  • Minimum 5 years industry experience in a similar role where you have been exposes to investigations

Morgan McKinley is acting as an Employment Agency in relation to this vacancy.

Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.

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