Senior / Analytical Support Officer

Job title: Senior / Analytical Support Officer

Company: GlaxoSmithKline

Job description: PurposeTo ensure the analytical equipment and computer systems in the quality laboratories are installed, validated, calibrated and maintained according to relevant quality standards and procedures. To ensure the equipment and computer systems related procedures are created and updated according to the QMS standards and guidelines and static data configuration for laboratory related systems are managed in a timely manner and meet regulatory requirements.Key ResponsibilitiesEnsure that analytical equipment is maintained and calibrated accurately and timely in accordance with site procedures, CAP and regulatory requirements.Lead and/or participate in investigations arising from laboratory equipment/computer systems events and propose effective CAPA to minimize reoccurrence.Perform periodic validation review of systems/laboratory equipment in a timely manner to ensure that the validation status is maintained and make recommendations for re-validation as required.Lead or participate in laboratory equipment validation in accordance with site procedures and regulatory requirements, inclusive of writing, reviewing and approval of validation related documentationsMaintain and support computer systems and laboratory equipment according to site change control and access control procedures.Perform accurate and thorough impact assessment on laboratory equipment, systems change control to ensure all impacted areas are adequately assessed and impacted documentation are updated in a timely manner.Revise, review and maintain laboratory procedures, instructions, methods to ensure compliance with regulatory, QMS, ATS and pharmacopoeia.Ensure a safe working environment in the laboratory and perform 6S inspection.Conduct effective training for laboratory staff on computer systems/equipment and relevant procedures.Ensure regulatory compliance, perform Level 1 audit and support L2 / L3 / L4 auditsSkills, Knowledge & ExperienceMin degree in science degree with min 2 years of experience in chemical, pharma or manufacturing industry for Junior roleMin degree in science degree with min 6 years of experience in chemical, pharma or manufacturing industry for Senior roleGood knowledge of GxP and laboratory equipment/validationGood knowledge of quality, laboratory techniques and laboratory complianceGood knowledge of regulatory expectations ICH requirementsGood knowledge of analytical equipment capabilities and operational needsTo 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 – 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. 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’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.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.

Expected salary:

Location: Singapore

Job posting date: Mon, 17 Jun 2024 00:23:01 GMT

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