Senior QA Engineer: CAPA & Customer Audit Lead

WEST PHARMACEUTICAL SERVICES SINGAPORE PTE. LTD.; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

WEST PHARMACEUTICAL SERVICES SINGAPORE PTE. LTD. seeks a Quality Assurance lead to handle customer complaints, lead root cause investigations, and host audits. You will drive CAPA activities with cross-functional teams and mentor junior engineers in problem-solving methods to strengthen quality systems.

The role emphasizes LEAN improvement, adherence to ISO 15378 / 9001, and collaboration with multiple departments to ensure timely corrective actions and ongoing process enhancements.

Qualifications

• Bachelor's degree or equivalent experience in Engineering / Science.
• 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.

Responsibilities

• Support Customer QA Manager to achieve daily, weekly and monthly KPIs.
• 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.

Skills

Quality assurance

cGMP knowledge

Analytical skills

Excel skills

Communication skills

Independent working

LEAN Six Sigma

Auditing

Education

Bachelor's degree in Engineering or Science

Tools

Excel

Job description

WEST PHARMACEUTICAL SERVICES SINGAPORE PTE. LTD. seeks a Quality Assurance lead to handle customer complaints, lead root cause investigations, and host audits. You will drive CAPA activities with cross-functional teams and mentor junior engineers in problem-solving methods to strengthen quality systems.

The role emphasizes LEAN improvement, adherence to ISO 15378 / 9001, and collaboration with multiple departments to ensure timely corrective actions and ongoing process enhancements.