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As part of the new product introduction and product transfer activities, you will be supporting and leading operational 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 operation implementation of product transfer activities (i.e. SOP, Batch record, Operational risk assessment)
Provide QA oversight for implementation of electronic batch record (i.e. Manufacturing Execution System)
Lead the team on operational readiness for PPQ
Author, review and approve operational SOPs.
Act as QA approver for deviations, CAPAs, change controls and SOPs, ensuring timely, compliant closure.
Approve GMP drawings
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 assurance, validation or related roles.
Practical knowledge of current Good Manufacturing Practice (cGMP) and regulatory requirements.
Strong knowledge of cross contamination control
Experience in authoring and approving 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.
Preferred Qualification
If you have the following characteristics, it would be a plus:
Experience with electronic batch record implementation
Prior role leading or involved in operational procedure implementation for new product introduction or technical transfer projects.
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: https://www.linkedin.com/company/glaxosmithkline/life/gsksingapore
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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.
We are committed to creating an inclusive workplace and providing equal opportunities for all applicants. We embrace an agile working culture across our roles, so if flexibility is important to you please discuss opportunities with our hiring team. If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities, contact APACRecruitment.Adjustments@gsk.com. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.
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