QA Executive

ABOUT US

Kleen-Pak Products Pte Ltd is a leading manufacturer of premium hygiene, cleaning, and personal care wet wipes, trusted by businesses and consumers across the region. Certified to ISO 9001, ISO 13485, ISO 22716, EU MDR, FDA QMSR, Halal, and FSC standards, we operate fully automated manufacturing facilities across Singapore and Vietnam. Quality, innovation, and sustainability are at the core of everything we do.

We are looking for a hands-on and detail-oriented QA Executive to be a key contributor in our Quality team. You will own QA/QC operations, drive our eQMS implementation, and ensure product quality and regulatory compliance across our Singapore site — with touchpoints into our Vietnam operations.

This is a broad, impactful role suited to someone who thrives in a structured yet fast-paced manufacturing environment and takes ownership of both systems and day-to-day quality outcomes.

JOB DESCRIPTION

eQMS Implementation (QT9)

• Own the QA/QC scope of our QT9 eQMS implementation, covering document control structure, QC inspection form design, training matrix setup, and CAPA/NCR workflow configuration.
• Build and maintain QC inspection forms in QT9 based on existing Excel forms and R&D specification sheets, ensuring alignment across both Singapore and Vietnam sites.
• Configure job titles, skill sets, and training matrices so that document revisions automatically trigger relevant training assignments.
• Design comprehension quizzes for key documents, in consultation with the Senior Quality Manager.
• Coordinate with the QT9 vendor on configuration, troubleshooting, and system enhancements.

eQMS System Administration

• Serve as the primary QT9 system administrator post go-live — managing user accounts, access rights, module settings, and system integrity.
• Coordinate with HR on employee onboarding and offboarding to ensure timely account setup, training assignment, and deactivation.
• Monitor system performance and user adoption; escalate and resolve issues with the vendor as needed.

Quality Control Operations

• Supervise the Senior QC Inspector to ensure incoming, in-process, and finished goods inspections are conducted in accordance with approved procedures.
• Review and release inspection results for qualified materials and finished goods.
• Ensure all inspection records are accurate, completed at point of inspection, and fully traceable to batch, lot, and specification requirements.
• Support Production and R&D during product trials, process validation, and in-process quality issue resolution.

CAPA, NCR & Non-Conformance Management

• Initiate and manage NCRs and CAPAs arising from inspection failures, deviations, customer complaints, and audit findings.
• Lead root cause analysis, define corrective and preventive actions, track implementation, and verify effectiveness.
• Coordinate customer complaint investigations with relevant internal stakeholders.
• Maintain CAPA and NCR logs; provide trend analysis for management review.

Document Control & Training

• Manage controlled document revisions (SOPs, work instructions, forms), ensuring proper approval workflows and version control.
• Maintain the QMS document master list, keeping documents current, correctly classified, and linked to training requirements.
• Conduct GMP, HSE, and security awareness training for new hires and refresher sessions for existing staff.

QMS Compliance & Audits

• Support the maintenance and continual improvement of the QMS in compliance with ISO 9001, ISO 13485, FDA 21 CFR Part 210 & 211, EU MDR, Halal, and FSC requirements.
• Administer the Change Management process — ensuring all changes are evaluated, approved, implemented, documented, and closed per QMS and regulatory requirements.
• Support internal, external, supplier, and customer qualification audits; ensure ongoing audit readiness.
• Conduct routine GMP, 5S, facility, and compliance inspections; identify improvement opportunities and follow up on findings.

Laboratory & Facility Management

• Oversee in-house laboratory operations to ensure QC testing is performed to validated, compliant standards.
• Maintain inventory of laboratory consumables, reagents, and calibrated equipment.
• Manage pest control programmes and environmental monitoring, including indoor air quality where applicable.

Reporting & Continuous Improvement

• Prepare monthly QA reports covering quality trends, inspection performance, CAPA status, and KPI updates.
• Support supplier performance reviews for critical suppliers.
• Drive continuous improvement initiatives across QA/QC processes to enhance efficiency, product quality, and compliance.

Team Development

• Supervise and mentor the Senior QC Inspector on inspection procedures, system usage, and GMP compliance.

JOB REQUIREMENTS

• Bachelor's degree in Chemistry, Pharmacy, Chemical Engineering, or a related discipline.
• Minimum 3 years of hands-on QA/QC experience in a manufacturing environment, preferably in personal care, pharmaceutical, or FMCG.
• Solid working knowledge of ISO 9001, ISO 13485, GMP (cosmetics and/or medical devices), and 5S practices.
• Experience maintaining or operating a QMS, with strong understanding of document control, CAPA, NCR, and inspection processes.
• Demonstrated ability to investigate non-conformances, conduct root cause analysis, and implement effective corrective actions.
• Familiarity with internal, external, supplier, and certification audit processes.
• Good written and verbal communication skills in English.
• Strong attention to detail; able to work independently and manage competing priorities.