QC Microbiology Lead

JOB PURPOSE

• Support QC Microbiology Associate Manager to perform review, supervision, and analysis properly and correctly with maintaining agility following defined rules in the purpose of implementation Bayer and Authority regulations related to the Quality Control areas.

YOUR TASKS AND RESPONSIBILITIES

• Support QC Microbiology Associate Manager to ensure the team follow safety regulations for each stage of work and supervising each other in terms of cleanliness and tidiness of laboratory area.
• Contribute in Operational excellence and reduction complexity program with ideas of efficiency, strategic project and cost reduction and ensure implementation of QC improvement in the shop floor
• Scheduling and/or maintain master data in automatic scheduling system and lead day to day analysis activity (material, product, stability, environmental monitoring) including review related log book and ensure related documents available in timely manner
• In cooperation with related functions, supervise and setup priority of testing to be performed based on alignment with related function
• Support QC Microbiology Associate Manager to ensure all prerequisites testing available including but not limited to sample, documentation, glassware, lab supplies, proper condition and calibration of QC instrument.
• Writing final report of QC related data, included but not limited to stability study report, study related improvement, validation appendix and risk assessment.
• Perform investigation, provide documentation and manage timeline to perform OOS, OOT, OOL, NC and deviation investigation
• Support Associate QC Manager to perform evaluation of global CMS (Compliance Management System) implementation and ensure SOP in the area are valid, correct and updated
• Support QC Microbiology Associate Manager to provide data requested by stake holder related QC activity (e.g. data for PQR, OPV or project)
• In carrying out his/her duties and responsibilities always consider HACCP and Halal requirements.

WHO YOU ARE

• Bachelor degree on microbiology or pharmacy
• Able to work on shift model ((if required)
• Able to read, analyze and interpret Bayer guideline and international/ global guideline, writing report, business correspondence and procedure manual in English.
• Ability to manage good work atmosphere among internal team and with other teams.
• Having experience 3 years in QC laboratory particularly related scheduling and laboratory investigation
• Understands know how on current GMP as well as other relevant national and international regulation for pharmaceutical products (GMP codes)
• Computer literate for standard office operational.
• Skilled to work within an international team and has ability to work within team.
• Be able to resist any influence, which would hamper management decision making