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 and 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
- Required to work 12h rotating shift (Day/Night)
About You:
- Bachelor of Science majoring in Chemistry, Biochemistry or related scientific degree
- At least 1-3 years relevant experience depending on qualification, preferably in the bio-pharmaceutical / Pharmaceutical industry
- 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's and industry standards for analytical development and characterization
Job Type: Contract
Contract length: 12 months. Option to extend/convert subject to performance review.
