Senior QA Engineer (12 months)

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

To handle customer complaint / feedback and lead internal investigations to identify complaint root cause and CAPA’s. Host customer audits. Lead quality improvement projects.

Essential Duties and Responsibilities

• Responsible for providing support to Customer QA Manager to ensure daily, weekly and monthly KPls are achieved

• Manage customer complaints ensuring timely and accurate response

• Host customer audits and act as the company spokesperson during the audit

• Provide response to customers enquiries and chair meetings requested by customers on complaints

• Lead the internal investigation with relevant departments to identify root cause for customer complaints / audit findings

• Establish CAPA for the identified root causes together with the relevant departments

• Ensure that the CAPA’s are implemented on time and able to effectively address the root causes of the issue

• Drives a right-first-time culture by routinely analyzing complaints and audit trends to identify improvement opportunities

• Lead product quality and quality system improvement projects

• Is a champion of A4 and A3 problem solving and systematically put these methodologies into use to identify root cause of complaints and audit findings. Coaches and mentors plant team to build capability in the area.

• Supporting internal and shop floor audits, as required

• Lead/supports process improvements, cost reductions/savings, intermix prevention, contamination control, scrap reductions, quality improvements etc. through the implementation of LEAN concepts (including the use of the Kaizen suggestion system).

• Encourage and foster teamwork within the plant team

• Prepare reports timely to highlight QA statistics

• Train and coach junior engineers

• Support QA and Customer QA Manager to maintain the ISO 15378 / 9001 system

• Any other duties as assigned by QA and Customer QA Manager.

Education

• Bachelor’s degree or equivalent experience in Engineering / Science

Work Experience

• At least 5 years of experience in quality assurance in a Pharmaceutical or Medical Devices manufacturing environment

• Working knowledge of ISO 15378 and ISO 9001 or equivalent quality standards

• Good knowledge of cGMP requirement and strong quality mindset

• Familiar with primary packaging materials manufacturing processes and requirements

• Effective communication and interpersonal skills

• Strong excel and report development skills

• Strong analytical skills

• Ability to work independently

• Strong learning capacity

Preferred Knowledge, Skills and Abilities

• LEAN Six Sigma Green or Black Belt

• Certified Internal or Lead Auditor

• Quality Engineer certification is a plus

• Project Management certification is a plus

• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description

• Support and contribute in Lean Six Sigma programs and activities towards delivery of the set target

• Able to comply with the company’s safety policy at all times

• Highlight unsafe practices to responsible persons

• Proper use of Personal Protective Equipment (PPE)

• Work safely by not causing unsafe conditions or doing unsafe acts

• Able to comply with the company’s quality policy at all times.

• Work in accordance to the local and global procedures

• Compliance to GMP requirement

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 Apply.Accommodation@westpharma.com. 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.