Description:
Reporting to the Value Stream Lead within Operations this role ensures effective problem solving and closure of non-conformances within compliance to the Quality Management System.
Essential Duties And Responsibilities
- Objectively facilitating cross functional teams to the correct identification of the root cause and identifying robust corrective and preventive actions to avoid reoccurring problems and investigations.
- Responsible for completion of investigations in compliance with Quality standards
- Utilizing lean tools and problem-solving tools while improving the problem-solving process, for the enhancement of site processes and performance
- Responsible for gathering, trending and analysing data to accurately clarify problems and identify continues improvements across the business
- Ensures that investigations comply with the Quality standards implemented in the business
- Responsible for clearly documenting investigations within the required timeframes to meet business and compliance needs
- Participates in regulatory inspections to present and defend investigations when required.
- Ensuring the timely and effective closure of day-to-day quality issues.
- Proactively improve processes to deliver competitive advantage for both the Business and customer
- Coach and drive a culture of compliance and continuous improvement.
- Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
- Compliance to all site Environmental, Health and Safety requirements, training, and regulations.
- Compliance to all local site company policies, procedures, and corporate policies.
- Perform additional duties at the request of the direct supervisor
Basic Qualifications
- Must have a third level qualification in Engineering/Quality/Science.
- Must have 3+ years’ work experience in the Medical, Pharmaceutical, or high-volume regulated manufacturing environment