Job Description:
- Contribute to Life Science projects for Antaes Asia clients
- Ensure products manufactured meet approved company policies, processes and procedures
- Provide quality oversight of GMP manufacturing and support, including technical operations, engineering, QC Laboratory and supply chain activities
- Review completed incoming material inspection packages, Batch Records, Manufacturing Logs, product changeover/ line-clearance activities and administration of Quality Logs, e.g. QA Hold, QA tag out
- Release incoming material, process and product batches.
- Participate in investigations, arising out of non-compliance in incoming materials, QC testing, manufacturing processes, warehousing and product
- Participate in change management, including change coordinator and/or QA oversight roles to ensure change plan is managed and complies with applicable polices
- Perform regular walk-thru of manufacturing, engineering, warehouse and QC areas as required to ensure compliance is maintained at all times
- Participate and support new product introduction, operation excellence projects and other tasks as assigned by team
- Contribute to the promotion of Antaes services on top of assistance provided to clients
Job Requirements:
- Bachelor’s Degree in Biomedical Engineering, Biotechnology, Science or equivalent
- Minimum 2+ years of pharmaceutical, biopharmaceutical experience in Quality and/ or Compliance (GxP) environment
- Knowledge of quality/ compliance management as well as regulations and standard affecting APIs/ Biologics
- Ability to quickly know products and processes in order to assess quality issues
- Experience in SAP, Trackwise
- Candidate must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills
- Excellent communication skills, both written and verbal, in English
