Quality Manager Risk Assessment | Collins McNicholas

Quality Manager Risk Assessment

  • Reference: GY44299
  • Job Type: Permanent
  • Location: Mayo
  • Category: Science, Pharmaceutical & Food

As Manager of Quality Engineering  (Risk Management) you will provide leadership and advice to implement and maintain a Reliability Regime throughout the organisation, linked to the Quality Management System.  This means proactively guiding identification and removal of adverse influences on the production system that could challenge its reliability.  It includes the process design stage, process specification, procurement and provision of equipment and facilities, together with supply chain and day-to-day working practices.  The Reliability Agent will work closely with the Production and OPEX functions, together with a cross-functional team, and reports directly to the Associate Director Quality Compliance. 

Responsibilities:

People                                                                                                                                                                           

  • Maintain strong relationships with management and colleagues in the business units, support functions and the quality site and global functions.  Articulate the necessary reliability management requirements in a clear, concise and persuasive manner.

 Strategic                                                                                                                                                                             

  • To define, describe & document what the organization means by reliability management and work on developing a site wide framework for the regime.
  • Identify a suitable process by which the approach will be piloted.
  • Analyze and manage the risk management process for prospective changes (e.g. for process changes & new product introductions) and for issues arising (e.g. deviations) as deemed necessary by identifying, measuring, and making decisions in conjunction with the Associate Director Quality Compliance
  • Develop and implement appropriate risk-assessment models or methodologies
  • Demonstrate active support and involvement in successful progress of compliance initiatives to enhance the site quality program.
  • Represent the company in Ministries of Health inspections as required for discussions on the overall regime in place
  • Develop a structure that coordinates and manages the site’s approach to risk documentation including the creation or modification of SOPs that aligns with Quality System procedures and industry best practices
  • To liaise with Finance & Planning regarding metrics development, collection & review

 Management                                                                                                                                                  

  • Co-ordinate and direct the Production Reliability Regime for the site  
  • To manage the Production Reliability Regime in a facilitatory manner for new projects (prospective) & issues arising (reactive) with multi-functional involvement including the Quality function on the design & performance of regime methodology, Production on the implementation in commercial operations, Engineering on the application in process design, Validation on the application in tech transfer and validation
  • To train & mentor personnel on the principles of reliability management
  • To liaise with Finance & Planning regarding metrics development, collection & review
  • To identify & sponsor Continuous Improvement programs
  • Assess implications of new regulatory guidance and implement necessary changes from a Production Reliability perspective
  • Stay abreast of industry best practice as it relates to Production Reliability
  • Ensure effective recording, analysis and reporting of indicators for reliability management, ensuring  issues impacting performance are addressed and drive continuous improvement.                                           

 Administration/Meetings                                                                                                                                              

  • Ability to independently represent the Westport Campus at project meetings and make robust decisions in support of project needs ensuring quality needs are understood and implemented from a Production Reliability perspective
  • CORAL: Review and approval of assigned documentation as deemed necessary
  •    Review and approval of Trackwise records and associated documentation
  •    Attend all routine meetings as required or arrange an appropriate deputy. For example: Site Project  meetings/EH&S Meetings, ANDON Boards/APEX meetings as assigned.

 

Skills, Experience and Qualifications:

  • Proven track record in the Pharma/Medical Device environment.
  • Practical working knowledge of a manufacturing environment or a quality discipline would be an advantage
  • Third level Science qualification in Science, Engineering, Operational Excellence
  • Practical working knowledge of statistical data analysis and quality improvement tools and techniques an advantage.
  • Experience using proven risk management tools
  • Clear understanding of working within a regulated environment

 

For a confidential discussion and more information on the role/company please email your CV to: amy.oneill@collinsmcnicholas.ie


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Amy O’Neill

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  • Amy O’Neill
  • Recruitment Consultant
  • 091706718
  • Connect with Amy

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