Senior QA Validation Lead (GxP & Process)

GLAXO WELLCOME MANUFACTURING PTE LTD; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

GSK Singapore seeks an experienced QA professional to lead validation activities for major projects, ensuring compliance with cGMP and regulatory requirements. You will author validation plans, review reports, and provide QA oversight across cross-functional teams.

In this role you will drive validation strategy for new product introductions or technical transfers, assess changes and CAPAs, and mentor junior staff while upholding patient safety and data integrity.

Qualifications

• Bachelor's degree in science, engineering or related discipline (or equivalent experience).
• Minimum 5 years' experience in pharmaceutical quality assurance, validation or related roles.
• Practical knowledge of cGMP and regulatory requirements.
• Experience in authoring and approving validation documents and SOPs.
• Experience in assessing impact of changes, deviations and CAPAs on validation status.
• Strong communication skills 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.

Skills

QA Oversight

Validation Plans

Regulatory Knowledge

Communication

Cross-functional

Data Integrity

Technical Writing

Risk Assessment

Education

Bachelor's degree in science/engineering or related discipline

Tools

Equipment validation

Computerized system validation

cGMP awareness

Job description

GSK Singapore seeks an experienced QA professional to lead validation activities for major projects, ensuring compliance with cGMP and regulatory requirements. You will author validation plans, review reports, and provide QA oversight across cross-functional teams.

In this role you will drive validation strategy for new product introductions or technical transfers, assess changes and CAPAs, and mentor junior staff while upholding patient safety and data integrity.