AbbVie Operations Singapore Pte Ltd
Quality Operations Specialist
Job Nature : Perm
Position Level : Experienced
Qualification : Bachelor's / Honours,Masters / PhD
Quality Operations Specialist must assist site management to oversight the quality system execution on the manufacturing and production areas at all times. 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 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/Audit of completed Batch Records.
- Review of Manufacturing Logs as required.
- Support product change over/ line clearance activities as required.
- Perform Incoming Raw Material checks and release.
- 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 maintained at all times.
- Degree in Sciences, Biology, Chemistry, Pharmacy, Engineering or equivalent.
- Minimum 2 years of pharmaceutical, biopharmaceutical experience in Quality and/or Compliance (GxP) environment.
- This position requires knowledge of quality / compliance management as well as regulations and standards affecting APIs and Biologics.
- Experience in SAP, Trackwise are preferred.
- Ability to quickly know products and processes in order to assess quality issues.
- Total commitment to quality and maintain a high standard of work at all times.
- Demonstrates the highest levels of integrity and a strong work ethic.
- Good planning and scheduling skills.
- Good communication skills both verbal and written.
- Good interpersonal skills.
- To be based in Tuas.