Site Name: Singapore - Tuas

　　Posted Date: Dec 12 2023

　　The Career Conversion Programme (CCP) (Train-and-Place with Commitment to Hire) for Advanced Biopharmaceuticals Manufacturing Executives/Professionals is a talent development programme aimed at building the next generation of skilled manpower for Singapore's Biopharmaceuticals manufacturing industry in anticipation of hiring demand.

　　The training programme consists of 15 months of local attachment with GSK. Due to the nature of the programme, we can only consider Singapore Citizens and Singapore Permanent Residents. For more information, please visit Career Conversion Programmes (CCP) for Individuals

　　A certificate will be given to successful trainees upon completion of the programme.

　　Purpose:To lead and manage Site validation activities (as assigned) to ensure that validations are in compliance with company procedures, regulatory requirements and cGMP expectations.To provide QA compliance oversight over IT and Technical Services (as assigned).Key Responsibilities:Ensure site validation activites are compliant with Site procedures, regulatory requirements and cGMP expectations Author and maintain the quality system SOPs for validationProvide solutions to achieve validation requirements.Collaborate with Operations to define the validation schedule and support the timely completion of activities as per schedule.Drive efficiency, improvement and robustness in site validation systems and processes.Be the link with Global Validation for technical information, and standards roll out.Assess impact to validation and validation status during change management, and define appropriate validation requirements and approach to maintain validated status of systems.Assess impact to validation for incidents/deviations and ensure appropriate CAPAs are in-place to resolve issues and prevent recurrence.Perform Periodic Review and prepare the review report for systems and processes.Oversee Periodic requalification and Continued process verification to maintain the validated status of systems and processes.Conduct GSK internal audits and front as SME in external regulatory inspections.Provide QA Oversight to IT operations in areas of:QA consulation to review and approve SOPsReview and approve changes, deviations and CAPAsProvide QA compliance oversight to Technical ServicesInteract with TS personnel in day-to-day operations to ensure cGMP complianceBe the QA approver for TS activities including but not limited to

　　LSOPs, Deviation/Event, CAPAs, Change Controls, Quality Tag-Outs, Calibration & maintenance programmes, Pest control reportsInterface with Internal & External stakeholdersEffective interfaces with internal and external stakeholders to ensure effective communication with and cascades from Global functions.El-ISComply with company requirements on EHSSkills:

　　Education

　　At least University basic degree in a Science or Engineering discipline

　　 Technical A good understanding of cGMP regulatory and legal requirements as applied to quality assurance and validation of pharmaceutical manufacturingGood understanding of regulatory inspection requirementA good working knowledge of validation, preferably with hands-on experienceComputer skills in MS Office and familiar with web-based e-learning resourcesPotential or developing project management skills Business Ability to apply optimal quality assurance standards to promote a business edge Ability to facilitate business activities compatible to international regulatory environmentAbility to communicate effectively within site organization and across networkPotential or developing planning and organizational skillsCompetencies:Working knowledge of FDA/EU/ICH/WHO as well as other relevant regulatory and techincal guidelines.Quality performance mindsetVaccines manufacturing process understandingDemonstrated professional and ethical integrityFluency and proficiency in the English languageWhere will I be based?

　　You will be based at one of our manufacturing site in Singapore near Tuas .

　　How can I apply?

　　Applications are now open. Click on the button above to apply.

　　We recommend you apply as soon as possible, because we accept ongoing applications and offer positions on a first come, first served basis!

　　At GSK we value diversity and treat all candidates equally. We strive to make our recruitment process free of bias of any kind and aim to create an inclusive workplace at GSK. If you require any assistance, either to attend an interview or during the course of the recruitment process, please let us know.

　　Why Us?

　　GSK is 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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

　　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.

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