Title:  GMP Specialist

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.

Job Summary:

Support QA Manager in ensuring QC and Analytical Laboratories operate in accordance with cGMP requirements. Ensure quality is maintained when there are issues arising from laboratories processes. Other activities include supporting quality improvement projects.

Our main goal is to deliver products that are cost effective, but without jeopardizing the required standard of performance, reliability and quality.

All employees should perform their activities in accordance with the quality policy of the company all the time.

Essential Duties and Responsibilities:

• Support QA Manager and Laboratory Manager in achieving and maintaining compliance with cGMP standards within the QC and Analytical laboratories.
• Be local SME of Data Integrity and manage the local DI projects ( Excel Spread sheet validation、Audit Trail、computerized system validation etc ) independently.
• Ensure that the documentation in QC and Analytical laboratories follows cGMP standards and support the Laboratories & QA  in the administration of documentation and electronic systems.
• Provide functional expertise and advice for verification of Excel Spreadsheets, set-up and validation of computerized systems, etc..
• Perform periodical review and audit data of QC and Analytical laboratory test results, computerized systems, Excel Spreadsheets, laboratory notebooks, electronic raw data, etc. to ensure cGMP compliance.
• Work with global team to drive Data Integrity initiatives, attend global DI routine meetings independently.
• Train QC and Laboratory staff in GMP relevant topics.
• Organize and maintain documents, as well as function as site GMP DCC, maintain the local documentation in Master Control System, documents distribute and archive, ensure documentation archived routinely and properly
• Support QA Manager to maintain the ISO 13485/15378 / 9001 system.
• Performs other duties as assigned based on business needs.

Basic Qualifications: 

• Bachelor's in scientific discipline preferred.
• Experience: 3-5 years of experience in quality assurance in a Pharmaceutical or Medical Devices manufacturing environment.

Preferred Knowledge, Skills and Abilities:

• The  job holder is aware of he/her special responsibility for quality and conducts his/her activities in accordance with the Company quality policy all the time.
  • Work to c GMP standards as required by the company.
  • Ensure good ‘5s’ and housekeeping are maintained at all time in the work areas.
  • Ensure that products confirm to the requirements of our customers.
  • Ensure products that are cost effective without prejudice to the required standard of   performance, reliability and quality.
  • Ensure results are documented in accordance to cGMP and procedure.
  • Ensure proper labeling of approved, rejected and on-hold parts.
• 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.

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 and/or a pre-employment drug screening.