Senior/QA Validation Specialist

You will ensure manufacturing facilities, processes, systems and methods meet regulatory and good manufacturing practice expectations. You will work closely with operations, engineering, IT and global partners to plan and deliver validation activities. Your work will support new product introductions, continuous process verification and regulatory inspections. We value clear communicators who solve problems, manage risk and drive improvements. This role offers growth, meaningful impact and the chance to help advance GSK's mission of uniting science, technology and talent to get ahead of disease together.

Responsibilities

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Provide quality oversight to validation projects for facilities, equipment, cleaning, analytical methods and computerized systems.
• Author, review and approve validation plans, protocols, reports and related SOPs.
• Assess validation impact during changes, deviations and investigations, and define appropriate validation steps.
• Conduct periodic review, continued process verification and recommend re-validation as needed.
• Act as subject matter expert during internal audits and external regulatory inspections.

Provide quality oversight to Engineering

• Interact with Engineering personnel in day-to-day operations to ensure cGMP compliance
• Be the QA approver for Engineering activities including but not limited to LSOPs, Deviation/Event, CAPAs, Change Controls, Quality Tag-Outs, Calibration & maintenance programmes, Pest control reports.

Why You?

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 2 years' experience in pharmaceutical quality assurance, validation or related roles.
• Practical knowledge of current Good Manufacturing Practice (cGMP) and regulatory requirements.
• Experience authoring and approving validation documents and SOPs.
• Experience assessing impact of changes, deviations and corrective actions on validation status.
• Strong communication skills with the ability to work effectively across functions and with external regulators.

Preferred Qualification

If you have the following characteristics, it would be a plus:

• Experience with computerized system validation, MES or electronic batch records implementation.
• Prior role leading validation for new product introduction or technical transfer projects.
• Knowledge of cleaning validation and method validation techniques.
• Experience participating in regulatory inspections as a subject matter expert.
• Project management experience and familiarity with continuous process verification approaches.
• Practical understanding of quality management systems and audit processes.

To learn more about Singapore GSK and our people, please click on this link:

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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