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Technical Investigator - Dublin

Technical Investigator - Dublin

West Pharmaceutical ServicesDublin, Leinster, IE
30+ days ago
Job description

Job Summary

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

    • Preferred Knowledge, Skills and Abilities :

  • A working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 and EU GMP is essential.
  • Ideally have a very good knowledge of Injection Moulding (standard process and Multi component), Processing, Ancillary equipment, and automation systems.
  • Ideally have excellent technical writing skills.
  • Must have effective problem-solving skills and working knowledge of root cause analysis tools such as 8D and A3
  • Must have a working knowledge of statistics and Data analytics, SPC, and ideally the use of statistical packages.
  • Must have excellent communication skills both oral and written.
  • Must have knowledge in computer systems; integrated manufacturing systems; word processing and spread sheets.
  • Must have excellent written and verbal communication skills as well as the ability to accurately document work performed.
  • Must be able to deal with all levels of employees and work across various departments

    • Travel Requirements :

  • Must be able to travel up to 5% of the time or when required

    • Physical & Mental Requirements :

  • Must be able to work in a fast-paced environment.
  • Must be ab