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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.
Key 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
Ensures that external service providers and suppliers for microbiology laboratory are managed in accordance to GSK requirements
Ensure regulatory compliance, perform L1 audit and support L2/L3/L4 audit as Microbiology Subject Matter Expert (SME). Ensure regulatory compliance, perform L1 audit and support L2/L3/L4 audit as Microbiology Subject Matter Expert (SME).
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 & Experience
Open to fresh graduates with a minimum degree in Microbiology or Life Sciences
Minimum 3-5 years’ experience in an analytical environment, preferably in the pharmaceutical industry.
Technical
Good knowledge of 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
Business
Good communication skills
Basic financial management skills
Basic knowledge of business process within GSK
People Management skills
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Skills
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
We are committed to creating an inclusive workplace and providing equal opportunities for all applicants. We embrace an agile working culture across our roles, so if flexibility is important to you please discuss opportunities with our hiring team. If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities, contact APACRecruitment.Adjustments@gsk.com. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.
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