Responsibilities:
- Sample storage and management
- Sample receipt of all routine and non routine samples
- Perform required benchtop/aseptic aliquoting
- Perform disposal of respective samples upon batch release. Perform disposal of respective reference samples beyond expiration.
- Liaise, arrange & perform shipment of required samples.
- SAP reconciliation check of each batch on the completeness of SAP transaction activities.
- Preparation of reagents/mobile phase to support analytical testing.
- Analytical testing (e.g. HPLC) and documentation of API / drug substance / drug product / finished product /
- Complaints / stability / packaging material samples to cGxP standards
- Analytical documentation of stability samples to cGxP standards
- Ensure all activities in compliance with cGxP, incl. data integrity
- Perform goods receipt for chemicals/reagents/consumables and stored them in respective locations upon receipt.
- Perform ordering of chemicals/reagents/consumables when it is below minimum order quantity.
- Perform lab housekeeping activities like glassware washing, general equipment cleaning and lab housekeeping
- Perform administrative documentation like Files/logbooks archiving, Controlled copy SOPs/logbooks request, Weekly reconciliation check on the CIRF printed documents and Weekly generation of weekly alarm report
- Comply with all HSE guidelines
- Detect and report potential accident, risks and propose solutions
- Responsible for participating in initial training and retraining
About You:
- Preferred: Previous experience working in a laboratory environment in the pharmaceutical industry (quality assurance, production), aseptic technique.
- Has completed apprenticeship as a laboratory assistant or equivalent training
- Collaboration; result-oriented
- Administrative activities and GMP and HSE-compliant, efficient production and documentation of standardized tasks in the infrastructure
- Breakthrough Analysis; Being Resilient; Operational Excellence; Continuous Learning; Digital & Tech Savvy
- Laboratory equipment; Quality Control (QC) Testing; Quality Control Sampling; related industry GxP standards and processes; Laboratory Excellence; Quality decision making
Duration : 12 months. Option to extend/convert subject to performance review.
