Loading...
Share this Job
Apply now »

Senior QA Engineer

Requisition ID:  35240
Date:  Jul 9, 2021
Location: 

Shanghai, Shanghai, CN

Department:  Quality

 

 

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

 

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

 

In this role you will

  • Lead the Quality shop-floor daily coordination, aiding in the reduction of defects and efficiency/effectiveness of quality reviews to minimize defects.  Support in the Implementation of the QA activities and maintain GMP compliance documentation within the facility.
  • Ensuring adherence to Pharmaceutical Industry standards & GMP guidelines within the QA Manual and QMS based on ISO 9001, 13485 and 15378.
  • Ensure compliance to customer specifications.

 

Essential Duties and Responsibilities:

  • Supervision of Deviations, OOS, Nonconformities, Batch card review and Product release, Rework etc, and ensure they are properly closed before products release.
  • Ensure required documentation is initiated for non-conforming material.  Ensure traceability, investigation and disposition of nonconforming material (return & rework/handling in SAP), as needed.
  • Monitor all relevant production areas for procedural adherence and Reporting manufacturing & procedural discrepancies.
  • Monitor the Quality KPIs, COPQ and Reporting in timely manner.
  • Provide Training and Communication Meeting to Shop Floor people.
  • Organize and Coordinate QMR.
  • Work independently with project team and participate on product quality and process improvement projects
  • Feedback to QA Manager any problems on process deviations and quality issues which are beyond your control.
  • Assist with internal audits/shopfloor audits and customer audits, as necessary.
  • Other duties as assigned

 

Education and Experience:

  • Bachelor’s degree or equivalent experience in
  • 5 Years of experience in Quality department and management experience.

 

Knowledge, Skills and Abilities:

 

  • Educated to Degree Level in a science-based subject, medical, chemistry or a materials science
  • Qualified Quality System Professional
  • Proven track record in Quality Assurance, Medical Device or Pharmaceutical Manufacturing background.
  • Internal Auditor Certificate.
  • Excellent communication skills, with good command in English.
  • Strong coaching and leadership skills.
  • With GMP experience will be considered priority
  • 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
  • Able to comply with the company’s quality policy at all times
  • Ensure support to achieve plant KPIs and Quality Objectives.

 

 

 

 

 

 

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 kimberley.eby@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 and/or a pre-employment drug screening.

Apply now »