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Quality Risk Management Specialist

Dublin, Ireland

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Quality Risk Management Specialist

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Job ID R0035774 Date posted 04/23/2021 Location Dublin, Ireland

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Job Description

JOB PURPOSE:

The Quality Risk Management (QRM) Specialist is responsible for providing systematic and operational expertise to the management of a comprehensive and integrated Quality Risk Management program at Takeda Grange Castle, which is underpinned by PTRB.  The encumbant will be responsible for ensuring a consistent approach to integrated quality risk management across the site’s GxP functions and will have the role of site SME and key contact for site operating units and functional areas for Quality risk management processes, risk register, and any associated IT workflow solutions.  Site SME for RMT Trackwise systems for the management of Quality Risk Assessment actions.

RESPONSIBILITIES:

  • The role has primary responsibility for providing expertise for the development, execution, and maintenance of Takeda Grange Castle’s local Quality Risk Management (QRM) program, while also performing other QA duties as part of the wider Quality Compliance Team.
  • Work with the Head of Compliance to design and develop the site QRM process.

GENERAL RESPONSIBILITIES:

  • The role requires a dynamic self-starter who will assume responsibility for the Site GMP QRM program.
  • Drive cross-functional engagement on site risk initiatives including the development and management of a local risk plan and register
  • Ensure site’s compliance to global Takeda QRM and risk register process requirements
  • Coordinate, plan, and facilitate risk management efforts for Takeda Grange Castle site products and processes as applicable
  • Provide technical expertise to site risk assessment teams as needed and work with colleagues across the site as part of the cross functional QRM team to ensure execution of the Site QRM Program.
  • Build upon and improve the existing QRM program and act as subject matter expert for QRM.
  • Lead the development of the local/site QRM training program (including development of tools and procedures) and provide guidance & training to operational personnel in support of a robust quality risk culture.
  • Support QRA facilitators across the site to ensure robust impact assessment and effective CAPA planning
  • The ideal candidate will be curious, highly motivated, and passionate about demonstrating continuous improvement. Strong judgment, critical thinking, attention to detail, organisation and influencing skills in working with different stakeholders will be required.
  • Work in partnership with Managers across other functional areas to build capability in QRM.
  • Participate fully in any cross functional training initiatives.
  • Participate on relevant internal / external communities of practice and/or forums to drive best practice sharing and industry expectations
  • Implementation of business processes for integration of Risk Management into relevant elements of the site’s Quality System
  • Drive and promote the corporate values of Takeda-ism within the workplace.
  • Actively foster, in cooperation with other TILGC 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 Head of Compliance.
  • Escalation and communication of risks through the established site governance and escalation processes.
  • Evaluate and report key performance metrics, analyze data and lead improvement initiatives relevant to the local risk program.
  • Ensure that schedule-based risk reviews occur at specified time periods.
  • Determine capacity needs for risk management and facilitation sustainability
  • May manage future direct reports based on site capacity needs.

EDUCATIONAL REQUIREMENTS:  

  • Bachelor's degree in Science/Engineering with a minimum 5 years’ experience in the pharmaceutical, biopharmaceutical, or medical device industry.
  • Experience in a QRM role within a Quality and/or Operations will be a distinct advantage.
  • Experience with Facility and Operations evaluations through application of Risk Management tools and methodologies such as: FMEA, HACCP, PHA, Risk Rank and Filtering, Risk reporting, etc.
  • Strong experience and thorough understanding / knowledge of cGMPs and applicable FDA regulations guidelines and industry best practices.

RELEVANT EXPERIENCE:

  • Strong experience and thorough understanding / knowledge of cGMPs and applicable FDA regulations guidelines and industry best practices.
  • Strong track record of scientific and analytical thinking
  • Capacity to manage time and priority constraints as well as manage multiple priorities simultaneously
  • Proven organizational / time management skills and ability to coordinate and prioritize multiple projects in a fast-paced, high pressure, deadline-driven environment.
  • Strong computer skills with MS Office (e.g. Word, Visio and Excel) and with relevant Quality System Databases (e.g. Document Management System, Quality Management System)
  • Demonstrates ability to be adaptable, maintain a positive outlook, and remain composed under pressure.
  • Strong interpersonal skills and ability to work effectively and collaboratively in a cross-functional team environment.
  • Strong written and verbal communication skills.
  • Proven ability to analyze and organize information logically.
  • Experience with troubleshooting / problem solving and risk assessment / mitigation. 
  • Minimum of 3 years’ experience in the pharmaceutical industry in Quality Assurance, including extensive auditing experience in non-sterile or sterile manufacturing facilities, exceptions may be considered.

SKILLS/COMPETENCIES:

  • Excellent working knowledge in auditing, GMP standards and regulations, including GMP requirements associated with manufacture, testing and release of API, Drug Product and ATMP products.
  • Excellent communication, technical, and organizational skills are required. Must be a team player prepared to work in and promote a team-based culture.
  • Comfortable making risk based recommendations based on science , data, or relevant experience. 
  • Strong written and oral communication skills, report writing and editorial skills.
  • An ability to work in a dynamic, fast-paced and goal driven environment.
  • Possess critical thinking, investigation and forensic data analysis skills with the ability to navigate and resolve complex systems/issues
  • Strong computer skills with MS Office (e.g. Word, Visio and Excel) and with relevant Quality System Databases (e.g. Document Management System, Quality Management System)
  • Experience with application of process improvement tools and methodologies such as LEAN/Six Sigma is desirable.

Locations

Grange Castle, Ireland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0035774
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