West Pharma Quality Specialist Complaints 

Ireland, Dublin 

146797647

Requirements:

• Must have a third level qualification in Engineering/Quality/Science.
• Must have 2+ years work experience in a Medical Device manufacturing environment.
• A working knowledge of quality systems such as ISO 13485 is essential. Experience and knowledge of 21 CFR Part 820 and EU GMP is an advantage.
• Team player who can work effectively and proactively on cross-functional teams.
• Experience/understanding of complaint handling or CAPA processes are desirable
• Must have excellent communication skills both oral and written.
• Auditing experience to the requirements of ISO 13485 / EU GMP / 21 CFR Part 820 is preferred.

Essential Duties and Responsibilities:

• To coordinate and support complaint handling of product complaints received by customer
• Interface on an ongoing basis with customers to ensure requirements / concerns / complaints are communicated and corrective and preventive actions are closed in a timely and effective manner.
• To open, track and maintain records for complaints received by customers.
• Data entry into complaint handling system.
• DHR review of Medical Device to be conducted within the QMS
• Lead investigations into customer / material / product issues to ensure a thorough root cause, containment / corrective and preventive action is implemented.
• Develop technical product expertise to assess adequacy of complaint information from the field and review of complaint investigations.
• Support complaint trend analysis and issuance of key reports to relevant departments.
• Support risk management, risk analysis and health hazard analysis associated with complaint/post-market information.
• Support responses to Competent Authority queries.
• Understand and ensure compliance with internal procedures and external global regulatory requirements.
• Develop processes and systems in line with best industry practice.
• Executing internal process and system audits.
• Manage quality projects in support of continuous improvement eg. Lean Projects.
• Ensuring the timely and effective closure of day-to-day complaints issues.
• Interface with other departments on a daily basis.
• 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.