West Pharma Senior Quality Specialist Compliance 

Ireland, Dublin 

415066612

The primary responsibilities of the Senior Quality Specialist involve Systems over-sight customer focus within our all Quality Management Systems, relaying trends to Senior Management and implementing improvements on a continuous and pro-active basis.Ensuring site compliance to corporate, regulatory and customer quality standards will be at the forefront of the responsibilities. Reports directly to the Quality Compliance Manager

Requirements:

• Must have a third level qualification in Engineering/Quality/Science.
• Level 8 qualification in a technical or related field plus 5 years of demonstrated experience in the administration of Quality Systems, or a combination of education and experience.
• Must have 5+ years’ work experience in Medical Device or Pharmaceutical Manufacturing Environment.
• A thorough working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 / 21 CFR Part 4/ EU GMP is essential. Knowledge of 21 CFR Part 210 / 211 would be considered an advantage.
• Knowledge of and experience in setting up and maintaining an effective QMS.
• Accredited lead auditor against recognised quality standards in support of internal and supplier audits
• Have experience in the facilitation of quality risk management coupled with a good working knowledge of ISO14971.
• Experience of hosting regulatory audits from either the European or US authorities
• Must have excellent communication and written skills
• Must be able to work in a fast paced environment.
• Must be able to travel as required by the position.
• Must be able to organize and prioritize tasks; must be detail orientated and self-motivated.
• An ability to collaborate across functional lines and work effectively in a team environment
• Must be able to work independently on own projects while working concurrently with all departments

Essential Duties and Responsibilities:

• Understand and ensure compliance with internal procedures and external global regulatory requirements.
• Lead investigations related to Quality System related issues to ensure a thorough root cause, containment / corrective and preventive action is implemented.
• Support trend analysis and issuance of key reports to relevant departments.
• Support responses to Competent Authority queries.
• Support risk management, risk analysis and hazard analysis associated with complaint/post-market information.
• Actively participate as Lead Auditor in Internal & External Audit Schedule.
• Support of third party audits, control room set-up and management of general audit readiness throughout the business.
• Post Audit follow-up and reporting both internally & externally on action completion and verification of effectiveness to ensure audit findings are closed out satisfactory.
• DHR review of Medical Device to be conducted within the QMS.
• Responsible for the scheduling, data collection and co-presenting Management Review.
• Support and drive the improvement and culture for data integrity.
• Coach and drive a culture of compliance and continuous improvement.
• Develop processes and systems in line with best industry practice.
• Coordinate the monthly Quality Systems KPI reporting activity both internally and to corporate level.
• Support regulatory submissions as required.

• Interface with other departments on a regular basis to ensure adherence to West QMS, drive quality improvements and compile/relay trends and occurrences throughout the year.
• 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.

Delegation of Duties:

When absent from the site duties and responsibilities will be delegated to the following designates

Job Title:Specialist Complaints and/or Quality Systems Co-ordinator

(for Routine Quality System responsibilities)

Job Title: Quality Compliance Manager & Quality Manager

(for all responsibilities outside of routine Quality System responsibilities)