Responsibilities:

Perform biochemistry, analytical and raw material of in-process and marketed products for lot release in accordance with quality standards and procedures
Responsible for housekeeping duties in the lab. Perform Quality Tag Out for laboratory equipment such as freezer, water bath, etc.
Support laboratory operations including but not limited to method transfer, equipment qualification, calibration, cleaning and maintenance, purchase and receipt of reagents and consumables, waste management, reagent and media preparation, critical reagent management and document management
Review lot release data, identify testing discrepancies and participate in laboratory investigations
Participate in inspection and ensure that the laboratory and documents are in a constant state of regulatory compliance and inspection readiness
To assist in writing SOP documents, change plan or change records (document revisions) supporting continuous improvement of test procedures and assay sheet design
To carry out completion and review of GMP Documentation of data sheets or LIMS software
To carry out QC sample receipt, assay and release procedures
Support Audit preparation and any audit related activity
Reading and understanding the test procedure and the requirements per USP, JP and EP

About You:

Bachelor of Science majoring in Chemistry, Biochemistry or related scientific degree
Fresh graduate are welcome to apply.
Good working knowledge of cGMP and regulatory requirements related to Quality is preferred
Problem-solving and troubleshooting skills
Highly motivated and independent
Possess good interpersonal and communication skills
Knowledge of cGLP / cGMP, FDA, EMA and ICH guidance and industry standards for analytical development and characterization
Must be able to do rotating 12-hour shift work (day and night shifts)

Job Type: Contract

Contract length: 12 months. Option to extend/convert subject to performance review.

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