Collins McNicholas

KEY/ACCOUNTABILITIES:                                                                                             

This is a list of Core Duties and must not be taken as a definitive list. You may be asked from time to time to undertake other duties, either in or out of your area of responsibility as a Continuous Improvement person.

People                                                                                                                            

  • Work with the 12hr shift managers to ensure RCA is effective and CAPA exceuted.
  • Lead and motivate cross-functional teams during workshops through effective communication and by delivering clear action plans for team members.
  • Support relevant departments in the implementation of process improvements for the business unit.
  • Encourage and reward improvement ideas and results via formal and informal mechanisms.
  • Engage with all levels of the Business Unit and support functions.

 Strategic                                                                                                                       

  • Development of action plans for non-conforming KPI’s
  • Identify action plans to eliminate re-occurring issues within Unitdose Business Unit.
  • Identify and lead process improvement initiatives within the Business Unit.
  • Develop training modules in conjunction with the Business Unit Managers.
  • Identify areas to continuously enhance the performance of the business unit.

Management                                                                                                                  

  • Develop and follow their Leader’s Standard Work.
  • Lead process improvement projects to enhance the overall performance of the business unit and manage to closure: Examples include
  • Representing the company at client and regulatory facing meetings and audits.
  • Lead organizational RCPS and support technical and other RCPS sessions, this include ownership of Root Cause Problem Solving.
    • Complex Deviations which require a cross-functional investigation approach
    • Re-occurring issues.
    • Adverse Trends for Environmental Monitoring Program
    • Process Improvement Projects that support Efficiency, Safety and/or Quality
    • Projects arising from QMT, SMR and EER meetings.

 Administration / Meetings                                                                                           

  •   Co-ordinate the completion of process improvement initiatives in conjunctions with the business unit managers.
  •   Attend all meetings with updates on action items as required e.g. OPEX tiered meetings, batch release meeting

MAIN CONTACTS:

  • Business Unit Lead
  • Production Manager
  • Packaging Manager
  • Technical lead
  • QP for Business Unit
  • Business Support Personnel

KEY REQUIREMENTS

Education and Experience/Knowledge:

  • Proven track record in Projects Management – Yellow/Green Belt Certified
  • Proven track record in working collaboratively in cross-functional teams
  • Degree in a pharmaceutical science/ engineering discipline.
  • Clear understanding of working within a regulated environment.
  • Clear understanding of working within an operations environment.
  • Clear understanding of QMS & Risk assessment.

Behaviours/Value:

  • Passion for results: – Drive, high energy, maturity, and ability to work under pressure and deliver results; get things done (an action-oriented approach); overcome obstacles.
  • Decision Making: identify and understand issues, problems and opportunities whilst providing a viable solution.
  • Problem solving: Perform Root Cause Problem Solving (RCPS) to ensure that true root cause in identifies for issue and ensure appropriate CAPA is implemented to preventive re-occurrence.
  • Receptivity to feedback – Receptive to the ideas of others and welcome and accept constructive feedback, display humility where appropriate
  •  Relationship Building: establishing excellent working relationships with direct reports through a hands on approach and giving clear and concise instruction.
  • Communication: excellent communication and presentations skills, both written and oral – ability to present business data in a clear and concise manner to team members, managers, team members.
  • Strategy: developing and implementing site and business strategy. Ability to plan, organise, prioritise and schedule.
  • Adaptability: Able to work in a fast, dynamic, environment whilst being able to adjust readily to meet unexpected constraints. Act as change agents for the site.

 

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