Job Description

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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 technical review of QC SAP Master Data changes when necessary.

To trouble-shoot on QC SAP issues and provide technical advice to site.

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 technical review of QC SAP Master Data changes when necessary.

To trouble-shoot on QC SAP issues and provide technical advice to site.

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

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 training activities for all users of the LES system (Eg. New Business Users, QA and LES Administrator).

Skills, Knowledge & Experience

Laboratory experience in the pharmaceutical industry (advantage)

University degree in a relevant science discipline with at least 3 years of relevant working experience or Diploma with at least 8 years of relevant working experience

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

#Li-GSK

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. 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. \xe2\x80\x8b

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.\xe2\x80\x8b

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GlaxoSmithKline