Senior Quality Engineer

West Pharmaceutical Services Singapore Pte Ltd; Singapore; Sur place; SGD 90 000 - 120 000; Plein temps

Résumé du poste

West Pharmaceutical Services Singapore Pte Ltd invites a seasoned QA professional to oversee quality systems and regulatory compliance across manufacturing operations in Singapore.

You will coordinate with cross-functional teams to maintain cGMP standards, drive CAPA, change control, investigations, and continuous improvement initiatives, while mentoring QA engineers and ensuring timely closure of audits and reports.

Qualifications

• Bachelor's degree in engineering or relevant field
• 5-8 years' QA experience
• Familiarity with SAP, cGMP, Lean principles, Power BI and ISO standards
• Experience in medical device/pharma manufacturing is preferred

Responsabilités

• Ensure products and processes meet internal, external quality standards and regulatory requirements
• Lead and contribute to safety and quality improvement initiatives aligned with plant KPIs
• Lead QA department meetings to drive on-time task delivery
• Manage quality platforms (OOS, deviations, change control, CAPA, document control) to meet KPIs
• Provide end-to-end quality oversight across departments to address non-conformance and timely delivery
• Monitor and improve quality programs to support operational excellence and compliance
• Compile monthly quality metrics and highlight trends for improvement
• Train QA Engineers and junior staff on quality processes
• Lead internal and shop floor audits to ensure quality standards

Connaissances

SAP

cGMP

Lean principles

Power BI

ISO standards

Formation

Bachelor's degree in engineering or relevant fields

Description du poste

Job Summary:

In this role, you will

• Provide end-to-end partnering to provide quality oversight to ensure alignment with stakeholders, customers and patient expectations

• Manage quality system platforms (Out of specifications (OOS), deviations, change control, Corrective and Preventive Actions (CAPA) and/or Document Control)

• Lead / participate in safety & quality enhancement initiative to drive continuous improvements within and across departments

• Promote quality culture and culture of continuous improvement

Essential Duties and Responsibilities:

• Ensure that all products and processes adhere to both internal and external quality standards, including regulatory requirements

• Lead and contribute to safety and quality improvement initiatives aligned with plant KPI and objectives

• Lead QA department meetings to drive on-time tasks deliverables

• Manage quality platforms (Out of specifications (OOS), deviations, change control, Corrective and Preventive Actions (CAPA) and/or Document Control) ensuring alignment with plant KPI and objectives

• Provide end-to-end partnering to provide quality oversight, collaborating with assigned departments to address internal non-conformance promptly while meeting delivery targets

  • Oversight of OOS, deviations, change control and validations to ensure compliance and timely closure

  • Provide guidance to batch tracing and batch disposition

  • Participate in A3s, providing quality guidance to root cause analysis, effective CAPAs

  • Provide training on GMP-related topics

  • Involve in CAPA management, compliance and timely closure

  • On time review and approval of documentation and procedures

• Monitor, assess and improve quality programs to support operational excellence and compliance

• Compile and analyze monthly quality metrics, highlighting trends and areas for improvement

• Provide guidance and training to QA Engineers & Junior QA Engineers and/or other team members on quality-related processes and practices

• Lead and participate in internal and shop floor audits, ensuring compliance with quality standards

• Support and contribute to Lean Sigma program and activities towards delivery of the set target

• Assist the QA Manager in ensuring compliance with the ISO 15378 / 9001 requirements

• Maintain accurate and comprehensive quality records and reports to support compliance, audits and continuous improvement processes

• Other duties as assigned by the superior

Basic Qualifications:

• Academic qualification of bachelor's degree in engineering or relevant fields

• Preferably 5-8 years' work experience in QA related activities

• Familiarity with SAP, cGMP, Lean principles, Power BI and/or ISO standards is advantageous

• Preferably with exposure to medical device, pharmaceutical or related manufacturing environment

Preferred Knowledge, Skills and Abilities:

• Comprehensive understanding of relevant standard operating procedures in accordance with company policy related to the position covered by this Job Description

  • Contribute to Lean Sigma initiatives and activities aimed at achieving set targets, minimize waste, and promoting efficient work execution

• Adherent to the company’s safety policy consistently

  • Ensure use of Personal Protective Equipment (PPE) in respective work environments for all members

  • Report unsafe conditions or acts to responsible personnel for corrections and improvements.

• Always commit to the company’s quality policy

  • Ensure gowning procedures are followed at work environments for all members

  • Lead monitoring / improvement activities to enhance operational support activities

  • Participate in establishment and maintenance of documented procedure

• Good knowledge of cGMP requirement and strong quality mindset

Physical and Mental Requirements:

• Manufacturing environment

• 20/30 Vision minimum, at near and/or far with at least one eye with or without corrective lenses and no color deficiency