Job Description

At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?
There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.
We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.
Job Summary
Reporting to the Design & Quality Assurance Director, the job holder will be the QA lead supporting West proprietary design & development projects (in Elastomer & Primary Containment) with key focus and responsibility around the interpretation, application of and compliance to relevant standards, regulations and internal procedures. The Senior Quality Engineering Specialist will manage the quality aspects of West proprietary design & development projects; will provide West proprietary design & development teams with guidance on design quality-related issues and design control best practices; and drive a culture of compliance and continuous improvement within West proprietary design & development teams.
Essential Duties and Responsibilities

• Responsible for ensuring proprietary design & development projects are executed in compliance with relevant regulations; regulatory requirements; international standards; and enterprise and local procedures.
• Identify and support the use of improved quality practices by R&D teams during design control activities; and facilitate the smooth integration of quality requirements into design processes.
• Report on the progress of projects; identify successes; and drive compliance.
• Escalate quality-related issues to the Design & Quality Assurance Director or designee, as required.
• Review and approve relevant design history file documents; product drawings; component specifications; labelling; procedures.
• Support design transfer activities for commercial and launch readiness and sustainment.
• Review and approve test method validations (protocols and reports).
• Review and approve design verification and design / process validation documents (e.g. protocols & technical reports).
• Facilitate and support the completion of projects up to and including PQ.
• Responsible for reviewing and approving Risk Management Plans, risk assessments and Risk Management Summary Reports for proprietary design & development projects.
• Facilitate and/or participate in risk assessment meetings with proprietary design & development teams.

Education

• Degree in Chemistry, Engineering or Quality discipline

Work Experience

• 5 to 7 years working in a high-volume regulated manufacturing environment.
• Desirable: Regulatory Affairs experience

Preferred Knowledge, Skills and Abilities

• Must have practical experience working with design teams and providing design assurance support according to international regulatory requirements.
• Working knowledge of ISO 13485, ISO 9001, ISO 15378 and 21 CFR Part 820 is essential
• Work experience in the life science industry or another highly regulated, international environment would be considered an advantage
• Experience in Project Management
• Experience in process technology, by preference with elastomers.
• Risk Management experience within design and development with good working knowledge of ISO 14971.
• An excellent understanding of rubber and plastic manufacturing technologies, analytical methods and testing.
• Knowledge of analytical tools and methods, including statistics (Minitab preferred).
• Support and contribute to Lean Sigma programs and activities.
• According to the principles of health and safety at work (substantiated by the Safety Leadership Statement), the job holder is aware of his/her particular responsibility regarding work safety and acts accordingly at all times
• Able to comply with the company's quality policy at all times.
• The job holder is aware of his/her special responsibility for quality according to the company's quality policy and conducts his/her activities in accordance with the company quality policy at all times.
• The job holder respects all responsibilities arising from cGMP requirements and from ISO 13485, ISO 9001, ISO 15378, ISO 14971 and 21 CFR Part 820, as per the current versions and to any future amendments.

Travel Requirements
5%: Up to 13 business days per year
West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to . Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

Skills Required