Senior Quality Engineer

About the role

West Pharmaceutical Services is hiring a Senior Quality Engineer for an onsite position in Jurong, Singapore. The role provides end-to-end quality oversight so that products and processes meet stakeholder, customer and patient expectations, and works closely with assigned departments to close out non-conformances while meeting delivery targets.

Key responsibilities

• Manage quality system platforms such as Out-of-Specification (OOS), deviations, change control, CAPA and document control, ensuring alignment with plant KPIs and objectives
• Oversee OOS, deviations, change control and validations to ensure compliance and timely closure
• Provide guidance on batch tracing and batch disposition, and take part in A3 root cause analyses and CAPA management
• Lead QA department meetings, approve documentation and procedures on time, and compile and analyse monthly quality metrics
• Give training on GMP topics to QA engineers and junior staff, and lead and take part in internal and shop-floor audits
• Support Lean Sigma programmes and assist the QA Manager with ISO 15378 / 9001 compliance
• Maintain accurate quality records and reports, and follow safety, PPE and gowning policies

Required profile

• Bachelor's degree in Engineering or Science
• 5-8 years of experience in QA-related activities preferred
• Exposure to a medical device, pharmaceutical or related manufacturing environment preferred
• Minimum 20/30 vision at near and/or far with at least one eye, with or without correction, and no colour deficiency

Required skills

• Proficiency in Microsoft Office
• Advantageous: SAP, cGMP, Lean principles, Power BI and/or ISO standards
• Knowledge of standard operating procedures and a good understanding of cGMP requirements