Senior/Microbiologist (1-Year Contract)

7 days ago

Singapur, Singapore GlaxoSmithKline Full time

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)
  • 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 Requirements
  • 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 Requirements
  • Good communication skills
  • Basic financial management skills
  • Basic knowledge of business process within GSK
  • People Management skills

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.

GSK is an equal opportunities employer and welcomes applications from all sections of the community. We are committed to creating an inclusive and respectful work environment that reflects the diversity of the communities we serve.

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