Title:  QA Specialist, Documentation

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 manage document control and CAPA workflow, lead / participate in quality improvement projects.

Essential Duties and Responsibilities:

• Manage the plant document approval and distribution workflow ensuring it complies to the document control requirement. This include but not limited to plant procedures, validation protocols and master specifications.

• Manage CAPA system to ensure CAPA are closed on time and effective. This include organizing monthly quality system trend review, participate in A3 investigation meetings and challenge CAPA effectiveness, track correction / CAPA to ensure on time closure and ensure CAPA reports are accurately updated in SAP module.

• Manage plant GMP training which include organizing new hire GMP training; organize routine plant GMP training; and reviewing of GMP training materials.

• Handle new technology transfer projects and Quality team deliverables

• Prepare reports timely to highlight QA monthly and quarterly statistics

• Lead / participate in product quality and quality system improvement projects

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

• Any other duties as assigned by QA Manager.

Basic Qualifications: 

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

• At least 1-3 years of experience in quality assurance in a Pharmaceutical or Medical Devices manufacturing environment

Preferred Knowledge, Skills and Abilities:

• Working knowledge of ISO 15378 and ISO 9001 or equivalent quality standards
• Good knowledge of cGMP requirement and strong quality mindset
• Effective communication and interpersonal skills
• 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 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

Travel Requirements:

• NA

Physical and Mental Requirements:

• NA

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 and/or drug screening.