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