QA Validation Lead - GMP (Process & Cleaning)

GlaxoSmithKline; Singapore; On-site; SGD 90,000 - 150,000; Full time

Job summary

GlaxoSmithKline Singapore site seeks a QA professional to lead validation activities for major projects, ensuring compliance with cGMP and regulatory requirements while collaborating with Engineering, Operations and Regulatory colleagues.

The role offers clear career growth, hands-on impact on compliant supply, and opportunities to contribute to GSK’s mission of uniting science, technology and talent to get ahead of disease together. Strong communication and integrity are essential.

Qualifications

• Bachelor’s degree in science, engineering or a related discipline, or equivalent experience.
• Minimum 5 years’ experience in pharmaceutical quality assurance, validation or related roles.
• Practical knowledge of current Good Manufacturing Practice (cGMP) and regulatory requirements.
• Experience in authoring and approving validation documents and SOPs.
• Experience in assessing impact of changes, deviations and corrective actions on validation status.
• Strong communication skills with the ability to work effectively across stakeholders of different functions.

Responsibilities

• Provide QA oversight for validation projects covering cleaning validation and process validation strategy and execution
• Author, review and approve validation plans, protocols, reports and related SOPs.
• Assess validation impact for changes, deviations and investigations
• Act as QA approver for deviations, CAPAs, change controls and SOPs, ensuring timely, compliant closure.
• Provide subject‑matter expertise to cross‑functional teams (Engineering, Operations, IT, Regulatory) on validation strategy and execution.
• Support in preparing validation documentation and responding to technical queries for product submission.
• Apply up‑to‑date knowledge of regulatory guidance (cGMP, 21 CFR Part 11, ICH) and ensure validation practices reflect industry best practice.

Skills

Quality assurance

Validation

cGMP knowledge

Regulatory compliance

Cross-functional collaboration

Documentation

Education

Bachelor's degree in science/engineering

Tools

Equipment validation

Computerized systems validation

Job description

GlaxoSmithKline Singapore site seeks a QA professional to lead validation activities for major projects, ensuring compliance with cGMP and regulatory requirements while collaborating with Engineering, Operations and Regulatory colleagues.

The role offers clear career growth, hands-on impact on compliant supply, and opportunities to contribute to GSK’s mission of uniting science, technology and talent to get ahead of disease together. Strong communication and integrity are essential.