Purpose
Act as the site microbiology subject matter expert; provide microbiologist expertise and develop monitoring strategy and operation framework.
Ensure that all site utilities, water, environmental monitoring and product testing activities are properly analysed and executed, and the results recorded in full compliance with current Good Manufacturing Practice (cGMP) and regulatory requirements that meet the defined quality standards.
Responsibilities
- Ensures that all water, environmental monitoring, site utilities and product testing samples are analysed and tested according to the stipulated quality requirements so as to provide accurate test results for correct usage decisions. Develops a strategy for the site with respect to environmental monitoring and water systems. Perform microbiological risk assessment for all non-sterile products.
- Work with relevant functions to support method validation / verification for micro related methods, ensuring that the activities are carried out in accordance to the required standards and procedures.
- Ensures that external service providers and suppliers for microbiology laboratory are managed in accordance to GSK requirements.
- Contribute to the formulation and development of the operational framework of the labs (framework covers testing protocol, SOP, and other operational policies, procedures and guidelines), and implement the approved plan.
- Contribute and occasionally lead site and corporate projects in line with specifications and budget allocation.
- Ensure a safe working environment for the laboratory and perform 5S and Zoning inspection.
- Supervise, develop, and motivate assigned analysts to help realize their maximum potential so as to contribute towards achieving the objectives of the department.
- Ensure regulatory compliance, perform L1 audit and support L2/L3/L4 audit as Microbiology Subject Matter Expert (SME).
- Ensure timeliness and accuracy of the Compliance review of Pharmacopoeia & ATS and to ensure In place and In use of the Pharmacopoeia / ATS / QMS requirement.
- Lead or participate in investigation arising from micro related and utilities investigation, incidents and accurately assess the impact of the failure so as to make appropriate recommendations on remedial actions for follow-up.
- Work with the relevant R&D groups to support micro related activities and micro risk assessment for New Product Introduction, ensuring that the activities are carried out in accordance to the required standards and procedures.
- Work closely with external staff and at line level to enable the localization and transfer of technology / knowledge / methodologies into standard order fulfillment activities.
Knowledge, Skills, and Experience
- Min degree in microbiology, chemistry, or life sciences
- Min 3 years of experience in an analytical environment in pharmaceutical or life sciences industry
- Experience in GMP
- Basic knowledge and on-going awareness of regulatory requirements (includes safety) on controlled environment and water system
- Very good knowledge of microbiological test methods
- Good knowledge of manufacturing processes and plant layouts of GlaxoSmithKline Manufacturing
- Good communication skills
- Basic financial management skills
- People Management skills
To learn more about Singapore GSK and our people, please click on this link: https://www.linkedin.com/company/glaxosmithkline/life/gsksingapore
#Li-GSK
Why Us?
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 positively impact the health of 2.5 billion people by the end of 2030.
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.
