Quality Operations Specialist

Job Description:

1. Contribute to Life Science projects for Antaes Asia clients
2. Ensure products manufactured meet approved company policies, processes and procedures
3. Provide quality oversight of GMP manufacturing and support, including technical operations, engineering, QC Laboratory and supply chain activities
4. 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
5. Release incoming material, process and product batches.
6. Participate in investigations, arising out of non-compliance in incoming materials, QC testing, manufacturing processes, warehousing and product
7. Participate in change management, including change coordinator and/or QA oversight roles to ensure change plan is managed and complies with applicable policies
8. Perform regular walk-through of manufacturing, engineering, warehouse and QC areas as required to ensure compliance is maintained at all times
9. Participate and support new product introduction, operation excellence projects and other tasks as assigned by team
10. Contribute to the promotion of Antaes services on top of assistance provided to clients

Job Requirements:

1. Bachelor’s Degree in Chemical Engineering, Biotechnology, Life Science or equivalent
2. Minimum 2+ years of pharmaceutical experience in Quality and/or Compliance (GxP) environment
3. Knowledge of quality/compliance management as well as regulations and standards affecting APIs/Biologics
4. Ability to quickly know products and processes in order to assess quality issues
5. Experience in SAP, Trackwise
6. Candidate must be highly motivated, able to work independently as well as in a team, and have good organizational and oral and written communication skills
7. Excellent communication skills, both written and verbal, in English