Skills

Develop the SOP for non sterile products/ sterile products in production lines,

Develop the HVAC system qualification protocol for new factory, and re validation protocol for routine operation of HVAC system,

Develop the HVAC qualification report after carried out of protocol,

Develop Purified water system validation protocol and report after carried out the protocol,

Develop the Manufacturing process validation protocol and report basic on the data after carried out as per protocol,

Develop the technology transfer protocol and report after carried out the protocol,

Develop the IQ, OQ, PQ protocol for new warehouse/ renovation/ changes and report after carried out the protocol,

Develop the temperature mapping protocol in loading step, seasonal validation and report after carried out the protocol,

Develop the temp. mapping protocol for empty vehicles/ Cold box and report after carried out the protocol.

Refrences

Non sterile factory in Vietnam such as Stada VN- WHO GMP, http://www.stada.vn/

Non sterile factory in Viet Nam Nippon Chemiphar- WHO, Pmda GMP, invested by Nippon Chemiphar Japan; https://www.chemiphar.co.jp/english/

Sterile( betalactam) factory such as TENAMYD CORPORATION, https://tenamydpharma.com/

Logistic in pharmaceutical

Time and Spatial Flexiblity

Asia area,

Arab Emirates

European  and US area,

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