GSK

Micro Lab Supervisor

3+ months agoHsinchu, Taiwan

Site Name: Hsinchu
Posted Date: Jan 19 2021

[Responsibilities]

  • Lab activity management, meet business requirement. Document and protocol preparing and reviewing.
  • Manage laboratory's testing and activities that ensure the release of testing as per production and Logistics' need.
  • Testing data, report and trend data review. Ensure all the operation is according to site SOP and guide without compliance concern.
  • Trouble shooting and lead LIR, Deviation and Change Control. Be qualified with QTS and LIMS
  • Conduct the further investigation on "OOS" or "Atypical Results" and track CAPA / Commitments.
  • Ensuring compliance to existing specification and standard procedure.
  • Familiar with analytical core technology and participate in the projects from Corporate/Region to site, such as Lean Lab CDAS, LIMS.
  • Prepare and review Micro Lab validation or qualification protocols & conclusive reports on "Testing Methods", "Equipment/Instruments"...etc.
  • Conduct method transfer among sites
  • Conduct Micro Lab training
[Requirements]
  • Ability to conduct analysis with microbial methods like incubation, autoclave, identification etc.
  • Ability to conduct analysis with good pipetting & transferring, dilution, reagent management & handling practice.
  • Ability and experience to practice to use basic instruments like analytical balance, pH-meter, oven, BSC, autoclave etc.
  • Experience of compendia knowledge in maintaining good method reference.
  • Experience of GMP practice or GLP practice of micro lab
  • Well computer skill especially for Microsoft Office (Word, Excel, Power point, Access, Visio)
  • Fluent English reading and writing, average speaking.
  • Micro method development and validation execution
  • Ability and experience to use Microbial Lab related equipment like BSC, TOC,.. etc.
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