Title:  Specialist, Quality System and Project

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 lead the Technology Transfers from a Quality Assurance and Quality Systems standpoint between the sites and regions with ensuring compliance to Quality Management Systems procedures and protocols. You will drive the execution of ongoing Technology Transfers and provide input to and support Best Practices to ensure product equivalency is achieved. You will determine methods and systems that can continually accelerate Technology Transfers internally and with customers.

You will implement, harmonize and standardize elements of West quality systems as required by West Corporate QA. You will also support other quality related programs in the region, as and when needed.

Essential Duties and Responsibilities:

• Develop Transfer Strategy together with the Global/Regional NetOp Groups and assist receiving site to complete site readiness processes (QA) before start of transfer production batches.
• Provide input to and ensure consistency of the Technology Transfer Documents.
  • • Work with the Tech Transfer teams to prepare the Transfer documents for approval aligned with agreed RACI: Drive the standardization and streamlining of all Technology Transfer documents.
    • Coordinate with the other Technology Transfer QA Leads to ensure harmonization and standardization of documents.
    • Ensure consistency and standardization of the Summary report incorporating Customer summary reports.
    • Update and train out West Enterprise procedures as needed.
• Analyze content of the Tech Transfer documents including Risk Assessment data preparation.
  • • Advise on changes and mentor and coach Site QA Managers on enhancements and missing data.
    • Ensure that correct Critical Quality Attributes (CQAs) are challenged to prove product equivalency and mitigate identified risks.
    • Drive and embed a preventive action culture via root cause investigation, risk assessments in    collaboration with other departments and sites.
• Support customer approval process.
  • • Support and where needed lead, customer technical meetings for specific transfers.
    • Support Quality and / or Customer projects using appropriate project management tools as deemed necessary. This can include internal project such as quality improvement projects as identified via quality data and trending.
    • Support the Customer Notification process including the rules for notification and for customer approval.
• Supports sites as needed in regard to customer audits / complaint handling / site specific project as deemed required by the line manager.
• Interface with other West sites with respect to sharing of best practices and harmonization / standardization of West Procedures and practices.
• Responsibility for reporting/generating of quality data on a monthly, quarterly and or annual basis both internally and in support of customer meetings.
• Lead / support other Quality Improvements projects as directed by the line Manager.
• Support other QA functions in the plants where necessary.
• Other duties as assigned by manager.

Basic Qualifications: 

• Education or Equivalent Experience: bachelor’s in chemistry, Chemical Engineering, or other Science based program.
• Working knowledge of ISO 15378 and ISO 9001 or equivalent quality standards and good knowledge of GMP.
• Desirable: Six Sigma qualification e.g., green / black belt.
• Min. 3 years’ experience in a GMP working environment.

Preferred Knowledge, Skills and Abilities:

• This role requires to attend some evening calls with global / regional team.
• Effective communication and interpersonal skills.
• Ability to report technical details in a simple and concise manner.
• Good written and verbal communication skills.
• Working knowledge in Mandarin language will be an advantage.
• Proficient in Microsoft applications i.e., Word, Excel, PowerPoint and SAP system.
• Project management skills
• Customer Intimacy
• Collaboration
• Authority to approve TT documentation as per agreed RACI.
• Relationship building and contributing to team success.
• Strong analytical, communication, and interpersonal skills.
• Ability to work in a matrix environment.
• Must be able to travel as requested by the position.
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
• Able to always comply with the company’s safety policy.
• Able to always comply with the company’s quality policy.

Travel Requirements:

• Must be able to travel up to 10% of the time.

Physical and Mental Requirements:                   

• Physical Requirements: Sedentary.

• Mental requirements: communication, quick decision making, interpreting data, reading or writing, public speaking, e.g., Must be able to express or exchange ideas with employees; Must be able to understand direction and adhere to established procedures.

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.