杭州招聘

• Instrument& Equipment management

Draft and review the procedure and report of equipment \instrument Calibration &PM &Qualification

Calibrate and qualify the equipment \instrument according to the documents or SOP(s)

Follow up the maintenance plan and preventive maintenance documents.

Ensure the SOPs and procedures are followed during all stages of calibration/ PM

Calibrate the pipettes according to the SOP

Manage and coordinate lab & Office EHS

• Change Control management

Monthly monitoring of the progress of raised changes and follow up with action plans

Able to write change controls, deviations and CAPAs in a logical and clear manner, and review these documents

Review of current equipment validation practices and propose changes to improve these practices

Fulfill a consultant role in the field of equipment validation for QA and the production department

• Laboratory Material management

Purchase laboratory materials & reagents & supplies, and follow purchase list

Define and manage the reagent, chemical, kits and critical material receiving and registration process within QC

Manage and organize reagent, chemical and critical material distribution to QC labs according related SOP

Compile and draft documentation for reagents management to be GMP compliant

Compile and ensure completion of reagent management

Manage and coordinate lab & Office 5S

REQUIREMENTS:

• Knowledge of cGMP requirements
• A minimum of one years of GMP experience in a biotech or sterile pharmaceutical manufacturing environment, or the equivalent, is desired.
• Prior work in maintaining GMP biotechnology and/or sterile process equipment is required is desired
• Proficient in computer skills and MS Office applications
• Excellent written and verbal communication skills.
• Excellent written and spoken English communication skills

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