Responsibilities:
- To provide an effective testing and analytical service to the plant ensuring that products manufactured are tested
- To specification on time and plant quality and safety goals are met.
- Ensure that all raw material, in-process and finished product testing and method transfer testing is carried out per
- Schedule and per GMP. Ensure that records are maintained to appropriate requirements.
- 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 equipments 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.
Requirements
- Min. Degree in Biochemistry / Bioengineering or related science field of studies
- Prior QC lab / HPLC & GC experience required
- Comfortable to work 12 hours shifts
Interested candidates please send your updated resume in MS Word Format to:
Subject: QC Lab Analyst
or call 6736 3280 and ask for Kate
EA Personnel: Kate Leau Wei Xuan (R1552331)
Company Registration No.: 99C4599
