Senior QA Executive - Validation at GSK

Singapore, , Singapore -

Full Time

Start Date

Immediate

Expiry Date

18 Jun, 26

Salary

0.0

Posted On

20 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Validation, Quality Assurance Oversight, Cleaning Validation, Process Validation, SOP Authoring, Deviation Assessment, CAPA Management, Change Control Approval, cGMP Knowledge, 21 CFR Part 11, ICH Guidelines, Computerized System Validation, Project Leadership, Cross-functional Collaboration, Regulatory Guidance, Problem Solving

Industry

Pharmaceutical Manufacturing

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, utilities, facilities and computerized systems (including CSV lifecycle activities). Lead the team on cleaning validation and process validation strategy 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 of validated equipment, utilities, facilities and computerized systems (e.g., calibration, preventive maintenance, alarm management). 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. 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. Preferred Qualification If you have the following characteristics, it would be a plus: Experience with computerized system validation Experience with method validation and pharmacopeia requirement Prior role leading or involved in validation strategy 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 #Li-GSK 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. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.

Responsibilities

The role involves supporting and leading validation activities for major projects, including equipment, utilities, facilities, and computerized systems, while ensuring compliance with quality systems. Responsibilities include authoring validation documentation, assessing validation impact for changes, and acting as a QA approver for deviations and CAPAs.