QC Specialist SAP (Contract)

Site Name: Singapore - Tuas Posted Date: Feb 7 2023 To learn more about Singapore GSK and our people, please click on this link: https://www.linkedin.com/company/glaxosmithkline/life/gsksingapore Purpose To provide technical support in LES and/or SAP to site on QC-related master data topics. Key Responsibilities Area Manage QC SAP & LES related activities and to provide support and technical expertise to ensure that manufactured products meet applicable regulatory standards and guidelines with respect to Quality control operations. Provides technical support on QC SAP and/or LES related activities. Lead root cause analysis for deviations (Critical, Major and Minor deviations) and follow through the unplanned event with QA. Manage deviations (Critical, Major and Minor deviations) including complex deviations and unplanned events and follow through with QA with minimum guidance. Manage Change control (AL1/2/3). Handle CAPA and Change control (AL1/2/3) tasks. Manage complex tasks such as continuous improvements, department and site projects and initiatives etc with guidance. Author of SOPs/ protocols/ reports/ trend analysis/ deviations. Support the periodic assessment of methods used on commercial products. Supports the investigation system in QC Coordinates the reports for invalids, atypical results and OOS. Subject-matter-expert (SME) / audit fronter for assigned topics. Manage ad-hoc tasks. Supports the SAP system and related topics in QC Coordinates and performs changes in monographs/ inspection plans for existing and new materials. Provides guidance, support, and technical expertise on SAP related matters Supports the LES system in QC Coordinates and performs lifecycle management of LES test method templates/master data in LES system. Provides guidance, support and technical expertise on LES-related matters. Manages business activities and implementation of test methods in LES system Conduct demo, mock-up, prototypes and dry-runs in QC Laboratories. Provide guidance to personnel (eg. QA and QC personnel) on the review and approval of new test methods. Manages the training program of LES system Contributes to the development of the training material and transfer of knowledge to all users Supports training activities for all users of the LES system (Eg. New Business Users, QA and LES Administrator). Manages reporting of LES system Coordinates reports and escalate issues to local and global teams accordingly (Eg. By initiating LES IT tickets) Report achievements and escalate issues to local and global teams accordingly (Eg. By initiating LES IT tickets) Interacts with different teams across the GSK Vaccines (Eg. IT, SAP, QC etc) Supports the technical review of QC SAP Master Data changes when necessary. To trouble-shoot on QC SAP issues and provide technical advice to site. Proposals & Recommendations Proposal of CAPs/ solutions for any issues/ deviations/ exceptions/ risks. Staff training Proposals of QC improvement projects and strategies. Skills, Knowledge & Experience Laboratory experience in the pharmaceutical industry (advantage) Diploma with at least 4 years of relevant working experience or experienced QC. Competent technical skills in the following: Common laboratory techniques (advantage) Computer system validation Knowledge of cGLP & CGMP Preferably with knowledge of statistics Preferably with knowledge of product review/ SAP Effective report writing skills Planning and organizing skills Good interpersonal skills Effective team player Leadership and problem-solving skills with analytical and logical thinking Why GSK Uniting science, talent, and technology 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 organization 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.
Li-GSK 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. 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. 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.