West Pharma Senior Specialist Quality Systems 

Ireland, Waterford 

908290997

Job Summary:

To ensure quality and technical standards are in place and in use ensuring product and service consistently meets customers’ requirements.

Developing and implementing continuous improvement programs covering production processes and quality management systems

Analysis of quality problems to identify root causes and implement corrective action to reduce risk of quality failure.

Essential Duties and Responsibilities:

The person will have a strong understanding of the requirements of and the implementation of quality management system and technical standards.

• Management of customer complaints
• Lead and perform risk assessments and implement control plans.
• Ensure non conformances/deviations/complaints are investigated and assessed for root cause and identification and closure of effective CAPA’s
• Support quality systems implementations and relevant training
• Lead in Continuous Improvement of Quality processes
• Interact and collaborate with Operations and other functions and West sites to support production and timely resolution of issues and investigations.
• Host Audits
• Complete supplier assessments
• Ensure compliance with customer agreements and specifications
• Perform Document Controller tasks as required
• Monthly and quarterly reporting of Quality KPIs
• Participate in internal audit and Shop Floor audit program
• Maintenance of professional and technical knowledge by attending educational events, reviewing publications, establishing networks and benchmarking.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all local site Environmental, Health and Safety regulations.
• Compliance to all local site company policies, procedures and corporate policies.
• Perform additional duties as requiredAct in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all local site Environmental, Health and Safety regulations.
• Compliance to all local site company policies, procedures and corporate policies.
• Other duties as assigned.

Basic Qualifications:

Degree in a Quality, Science or Engineering or equivalent discipline.

Quality Auditing certification.

Lean/Six Sigma certification.

Supervisory experience.

Preferred Knowledge, Skills and Abilities:

• 5+ years’ previous industrial experience of working as a Quality Engineer or Quality specialist in an ISO13485, EU GMP or 21 CFR Part 210,820 or 211 design or manufacturing environment. Aseptic or sterile manufacturing experience is desired.
• Review and approval of facility, equipment and process validation
• Analytical Method, Equipment/Process and Software Qualification
• Involvement in new product introduction or technical transfer activities.

Competencies

• Quality planning and communication skills.
• Strong technical writing ability.
• Ability to liaise with customers and suppliers in an informed professional manner.
• Excellent IT, communication and interpersonal skills using current office technologies.
• Ability to work on own initiative, coupled with involvement on cross-functional teams.
• Interest and willingness to learn new skills and take on new tasks
• Strong sense of urgency and flexibility

Travel Requirements:

• Must be able to travel up to 10% of the time.