Job Description

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)

Responsibilities:1. Ensure site validation activities are compliant with Site procedures, regulatory requirements, and cGMP expectations\xc2\xb7Author and maintain the quality system SOPs for validation.\xc2\xb7Define validation approach that is technically sound and are compliant.\xc2\xb7Author Validation Plans and Reports, including Continuous Validation Plan\xc2\xb7Review and approve validation deliverables\xc2\xb7Provide solutions to achieve validation requirements\xc2\xb7Collaborate with Operations to define the validation schedule and support the timely completion of activities as per schedule\xc2\xb7Drive efficiency, improvement and robustness in site validation systems and processes\xc2\xb7Be the link with Global Validation for technical information, and standards roll out\xc2\xb7Assess impact to validation and validation status during change management, and define appropriate validation requirements and approach to maintain validated status of systems\xc2\xb7Assess impact to validation for incidents/deviations and ensure appropriate CAPAs are in-place to resolve issues and prevent recurrence\xc2\xb7Perform Periodic Review and prepare the review report for systems and processes\xc2\xb7Oversee Periodic requalification and Continued process verification to maintain the validated status of systems and processes\xc2\xb7Conduct GSK internal audits and front as SME in external regulatory inspections\xc2\xb7Provide support for all activities related to GPS (e.g. Tiers, Gemba, DMAIC etc) for continuous improvement2. Provide QA Oversight to IT operations in areas of:\xc2\xb7QA consultation to review and approve SOPs\xc2\xb7Review and approve changes, deviations and CAPAs3. Provide QA compliance oversight to Technical Services\xc2\xb7Interact with TS personnel in day-to-day operations to ensure cGMP compliance\xc2\xb7Be 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 reports4. Interface with Internal & External stakeholders

• Effective interfaces with internal and external stakeholders to ensure effective communication with and cascades from Global functions

5. EHS

• Comply with company requirements on EHS

Knowledge, Skills, and Experience:ProfessionalAt least University basic degree in a Science or Engineering disciplineAt least 2 years\' experience in pharmaceutical industry or related regulatory fieldsAt least 5 years for Senior QA Validation Specialist roleTechnicalA 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 skillsBusinessAbility to apply optimal quality assurance standards to promote a business edgeAbility to facilitate business activities compatible to international regulatory environmentAbility to communicate effectively within site organization and across networkPotential or developing planning and organizational skillsTo learn more about Singapore GSK and our people, please click on this link:#Li-GSKWhy GSK?Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s 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 \xe2\x80\x93 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.Important notice to Employment businesses/ AgenciesGSK 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.

GlaxoSmithKline