Quality Operations Specialist must assist site management in oversight the quality system execution
on the manufacturing and production areas at all times. The incumbent is required to observe, document,
discuss, and report quality adverse events related to the manufacturing of the product. QO Specialist
is responsible to ensure the highest quality and compliance of released batches at the AbbVie
Operations Singapore, Tuas Singapore site.
- Ensure that products manufactured at AbbVie Operations Singapore meet approved company policies, process and procedures.
- Participating in investigations arising out of product or manufacturing processes non-compliance.
- Review of completed Batch Records.
- Review of Manufacturing Logs as required.
- Support product changeover/ line clearance activities as required.
- Provide quality oversight support to manufacturing, engineering, QC laboratory and supply chain as required. Administration of Quality Logs, e.g. QA Hold, QA tag out
- Perform regular walk-thru of manufacturing areas as required. Proactively seek to improve and simplify site processes and procedure, specifically relating to the Operations function to ensure compliance is always maintained
- Bachelor’s degree in Natural Sciences (i.e. Biology, Chemistry), Pharmacy, or Engineering.
- This position requires 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
- Total commitment to quality and always maintains a high standard of work
- 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 skills both verbal and written
- Good interpersonal skills