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
In this role you will 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
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 Control 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.
Other duties as assigned
Basic Qualifications
Degree in a Quality, Science or Engineering or equivalent discipline
Preferred Knowledge, Skills And Abilities
Min 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.
Quality Auditing certification.
Lean/Six Sigma certification.
Supervisory experience.
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.
Travel Requirements
10%: Up to 26 business days per year.
West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post‑offer background screening.
#J-18808-Ljbffr