Job Description

PurposeTo assist the Laboratory Operations Manager to manage the infrastructure and support aspects of the Laboratory to ensure that the systems in place are compliant with defined quality requirements.
To ensure that all value stream specific process raw materials, non-routine samples, envoys, intermediates and final products are analyzed and the results recorded in full compliance with current Good Manufacturing Practice (cGMP) and regulatory requirements that meet the defined quality standards.
To ensure that all investigational samples or evaluation samples are analyzed and results recorded in full compliance with current Good Manufacturing Practice (cGMP) and regulatory requirements that meet the defined quality standards.
To ensure all new methods and specifications introduced as part of new product introduction or product lifecycle are validated or verified in compliance with
defined quality standards and regulatory requirements.Key ResponsibilitiesSupervise, develop, and motivate laboratory analyst to help realize their maximum potential so as to contribute towards achieving the objectives of the department. Provide technical training on laboratory instrumentation to laboratory analysts.Ensure that all data supporting the resolution of process and method issues have sufficient accuracy to allow for the correct actions to be taken to address the issue. Contribute to the formulation and development of the plans for the implementation of new testing technologies and methods.Ensure a safe working environment for the laboratory through participating or issuing safety risk assessment for product specific methods, or techniques or material and performing 6S inspection.Assist Laboratory Operation Manager in supporting laboratory budget management and Analytical Laboratory resource planning.Involve in the approving change that may have an impact on product
quality, validation and/or cGMP compliance. This may require
assessment of testing requirement, co-ordinate testing of samples and comment on change documentation and ensure closure of change. Upon completion, review and ensure closure of changes.Draft, compile, review and update appropriate laboratory documents
such as testing protocol, procedures and guidelines relating to GMP
and operational framework of the laboratory.Lead or participate in investigation arising from laboratory investigation, incidents and accurately assess the impact of the failure so as to make appropriate recommendations remedial actions for follow-up.Assumes the role of corporate ERP system BPE when required.Ensure regulatory compliance, perform GSK Management Monitoring
audit and support Independent Business Monitoring (IBM) and external audits.Ensure timeliness and accuracy of Pharmacopoeia & ATS review.Skills, Knowledge & ExperienceAt least a degree in chemistry.At least 1-4 years\' experience in an analytical environment, preferably in the pharmaceutical industry.GMP and GLP knowledgeUnderstanding product specification and method of analysisKnowledge of laboratory instrumentationLIMS and corporate ERP system knowledgeLaboratory support proceduresWays of working for new product introduction (NCE Support)Regulatory requirements for method validationGood communication skillsBasic financial management skillsBasic knowledge of business process within GSKPeople management skillsProblem solving skills (Troubleshooting skills)Project management 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