- Handling inspection and testing microbiologically of incoming materials, finished goods, bulks, stability samples, environmental monitoring, water and gases by ensuring that the processes are conducted according to the established procedures. Further, continuously reviews the SOPs used in this field to be up-dated as required to be in line with the up-dated quality guide and Bayer specifications.
- Perform analytical transfer from lab giver includes analytical development of Cimanggis and ensure appropriate related documents are available.
- Support QA in releasing process of finished goods by providing data in Laboratory Work Sheets as well as in the system.
- Any OOS and out of trend incoming materials, finished goods, bulks, stability samples, environmental monitoring, water and gases observed during analysis should be informed to QC Manager or Head of Quality to take action and decision and perform laboratory investigation and provide monthly basis report testing activities to the QC Manager.
- Support Development Team by coordinate any analysis activities to ensure every project fulfill its target timely.
- Control the Micro Lab. instrumentations are in qualification status and calibration period.
- Follow safety regulation for every step of analysis when performing analysis and control the micro lab area clean and tidy in order to HSE aspects.
- In cooperation with QC management staff to control and manage availability and stock of media, reference standard and other laboratory supply
- Contribute actively on Operational Excellence program with ideas of efficiency and cost reduction.
- Bachelor degree major in Pharmacist, Biology, or chemical.
- Having experience in microbiology testing and environmental monitoring analysis for minimum 3 years or 2 years supervisory level in microbiology analysis and environmental monitoring from other companies as a minimum.
- Understands know how on current GMP as well as other relevant national and international regulations for pharmaceutical products (GMP codes).
- Skilled, saving and critical in carrying out their duties and take notice provisions on hazards in the work environment and about environmental control.
- 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.
Tutup pada 18/November/2016
Graha Paramita Jl Denpasar Raya Kav 8 Bl D-2 Graha Paramita Lt 7 Karet Kuningan, Setia Budi Jakarta Selatan 12940 DKI Jakarta
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