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Quality Operation Associate


  • Ensure that products manufactured meet approved company policies, processes and procedures

  • Provide quality oversight of GMP manufacturing and manufacturing 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 policies.

  • Perform regular walk-through 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 management

About You:

  • Bachelor Degree in a Natural Sciences (i.e. Biology, Chemistry), Engineering, Pharmacy or other relevant courses

  • Prior knowledge of quality / compliance management as well as regulations and standards affecting APIs / Biologics

  • Minimum of 2+ years of pharmaceutical, biopharmaceutical experience in Quality and/or Compliance (GxP) environment.

  • Experience in SAP, Trackwise are preferred

  • Ability to quickly know products and processes in order to assess quality issues

  • Committed to quality and maintain a high standard of work at all times

  • Demonstrates the highest levels of integrity and a strong work ethic

  • Good knowledge of GxP requirements and regulations

  • Good planning and scheduling skills

  • Good communication and interpersonal skills both verbal and written

Submit your resume to
Only shortlisted candidates will be contacted. 
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