West Pharma Senior Specialist Quality Integrated Systems 

Ireland, Waterford 

936227324

In this role, you will provide quality direction, governance, and Quality best practices across the Quality Management System and the programs you support. This role supports multiple concurrent projects to ensure regulatory and quality compliance is maintained throughout the product development lifecycle, including manufacturing, commercialization, and life-cycle management. This role is also responsible for supporting and maintaining the Quality Management System (QMS) in compliance with applicable regulatory requirements. This role plays a critical part in ensuring product quality and patient safety through the effective execution of quality processes. This role will perform and support activities including product test, product assembly, batch record review, product investigations, corrective and preventive actions (CAPAs), out-of-specification (OOS) results, customer complaint handling, training oversight and metrics, document control activities, change management activities, internal and external audits, and supplier corrective actions.

You may ensure suppliers deliver products which comply with requirements and specifications. You may lead efforts to enhance the supply chain by addressing supplier and customer issues, improving quality processes internally and with suppliers, and executing quality strategies. You may play a key role in collaborating with cross-functional teams, guiding technical evaluations, and implementing improvements in the Quality Management System.

• Lead project planning activity and develop comprehensive project plans including scope, timelines, budget, resources, and project success criteria. Gain buy-in from project team and ensure an inclusive approach to project planning. Proactively identify gaps and risks to project success and implement mitigation strategies to minimize impact.
• Collaborate with cross-functional teams, internal and external to the laboratory, to coordinate project execution and ensure that project objectives and success criteria are met.
• Provide Quality direction to multiple concurrent product development programs to ensure product and process compliance to all applicable regulatory and cGMP requirements, including ensuring all relevant safety procedures are employed.
• Author, review, and/or approve design history documentation and design manufacturing documentation (e.g., product specifications, design verification and validation activities, FMEA risk documents, test methods, protocols, reports, manufacturing batch record reviews, etc.)
• Support the development and maintenance of product or process risk and hazard analysis in accordance with West policies and procedures and ISO standards.
• Perform and lead QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, audit findings, issue reviews, document control activities, change controls, configuration management, training curricula and requirements, etc. Provide direction on any nonconformance, deviation, or excursion that may occur and drive to closure. Author and review product development QMS procedures and work instructions.
• Meet company and departmental goals in the continuous improvement of all products, services and processes, including the West QMS.
• May work independently and with project teams to develop design control deliverables including quality plans, manufacturing and inspection documentation, test methods, and any other necessary quality records.
• May support quality assurance improvement activities by evaluating products, processes or materials in order to develop control or improvement strategies intended to improve the customer’s experience.

• Bachelor's Degree in Engineering or Science or equivalent experience required

• Minimum 5 years of experience in a regulated industry (e.g., Medical Device), including Product Manufacturing and Post Market Surveillance Activities required
• Demonstrated experience (4+ years) independently defining, planning, and executing projects in highly regulated environments with a track record of success required
• In-depth knowledge of cGMP regulations, ISO 15378 or ISO 13485, 21 CFR 820, ISO 14971 required
• Proficiency in standard project management tools and software (e.g. Microsoft Project, Excel) for planning, tracking, and reporting project activities, and proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point required

• Experience with MasterControl, SAP, Share Point
• Experience with ISO 11040, ISO 11607
• Expertise in quality management tools. Standards, policies, and procedures – APQP, PPAP, MSA, SQC etc
• Strong working knowledge of quality systems of the respective ISO norms
• Strong project management skills
• Proficient in computer system applications (SAP, master controls, etc) communication skills

• Manufacturing\Six Sigma Green Belt Certification or Black Belt Upon Hire preferred
• Quality\Certified Quality Technician-ASQ (CQE or CQA) Upon Hire preferred
• ISO 13485/15378/9001 Auditor or Lead Auditor Training / Certification Upon Hire preferred

• Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
• Excellent written and oral communication and interpersonal abilities, with the capacity to communicate complex technical concepts to diverse stakeholders.
• Critical reading skills and maintain high attention to detail, accuracy, and overall quality of work.
• Must be able to multi-task, work independently, work under time constraints, thrive in fast-paced environment, solve problems and prioritize.
• Strong problem-solving skills including root cause failure analysis methods.
• Observe and interpret situations, analyze and solve problems.
• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
• Must maintain the ability to work well with others in a variety of situations.
• Ability to make independent and sound judgments.
• Be aware of all relevant SOPs as per Company policy as they relate to this role
• Able to comply with the company’s safety and quality policies at all times