GSK
Senior/QAValidationExecutive(1-YearContract)
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optimal for Senior candidates.
“Senior/ QA Validation Executive (1-Year Contract) at GSK. Skills: QA oversight, Validation strategy, Validation execution. Provide QA oversight for validation projects. Lead cleaning validation strategy and execution”
Industry & Context.
Practical problem solvers
What They're Looking For.
Must Have
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 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, Communication skills with the ability to work effectively across stakeholders of different functions
Nice to Have
Experience with computerized system validation, Prior role involved in validation strategy for new product introduction or technical transfer projects, Project management experience, Familiarity with continuous process verification approaches, Practical understanding of quality management systems and audit processes
What You'll Do.
Provide QA oversight for validation projects
Lead cleaning validation strategy and execution
Author validation plans
reports and related SOPs
Review validation plans
reports and related SOPs
Approve validation plans
reports and related SOPs
Assess validation impact for changes
Assess validation impact for deviations
Assess validation impact for investigations
Act as QA approver for deviations
Act as QA approver for CAPAs
Act as QA approver for change controls
Act as QA approver for SOPs
Approve engineering activities
Provide subject-matter expertise to cross-functional teams on validation
Provide subject-matter expertise to cross-functional teams on validation
Support in preparing validation documentation
Respond to technical queries for product submission
How You'll Work.
Team & Collaboration
Cross-functional teams; Manufacturing teams
Process & Methodology
Project management
Full Job Description
As part of the new product introduction and product transfer activities, you will be supporting and leading validation activities for major projects at our Singapore site. You will ensure compliance to quality systems during validation activities and work closely with manufacturing and cross-functional teams. We value practical problem solvers who act with integrity, communicate clearly, and put patient safety first. This role offers clear career growth, hands-on impact on compliant supply, and a chance to contribute to GSK’s mission of uniting science, technology and talent to get ahead of disease together. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: * Provide QA oversight for validation projects covering equipment and computerized systems (including CSV lifecycle activities) * Lead the team on cleaning 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. * Approve engineering activities such as master data, calibration and preventive maintenance strategy * 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. **Basic Qualification** We are seeking professionals with the following required skills and qualifications to help us achieve our goals: * Bachelor’s degree in science, engineering or a related discipline, or equivalent experience. * Minimum 5 years’ experience in pharmaceutical quality assur
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