Senior Quality Operations Specialist (Bio)
- Singapore
- Permanent
- Full-time
- Ensure that products manufactured at AbbVie Operations Singapore meet approved company policies, processes and procedures.
- Execute and provide oversight on procedures to ensure that incoming materials including raw materials and commodities received at ABS meet approved company policies and processes.
- Lead and provide guidance in investigations arising out of non-compliance in incoming materials, QC testing, manufacturing processes, warehousing or product. Perform root cause analysis and identify effective corrective action and preventive action.
- Perform audit or review of 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.
- Responsible for Annual Product Quality Review and Product Quality Assurance.
- Perform regular walk-thru of manufacturing, engineering, warehouse and QC areas as required to ensure compliance is maintained at all times.
- Responsible to perform data trending independently and champion improvement kaizen with respective areas for continuous improvement.
- Proactively seek to improve and simplify site processes and procedure, specifically relating to the Operations function to ensure compliance is maintained at all times.
- Lead and support quality system implementation as appropriate.
- Lead and act as Subject Matter Expert in change management. Activities including to lead/ participate in cross functional team risk assessment and provide guidance in change management process.
- Primary contact as site change coordinator and liaison with global change coordinator to ensure all the global change proposal is managed and administrated in accordingly to the procedure.
- Participate and support new product introduction, operation excellence projects assigned by management as appropriate.
- Bachelor Degree in a 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 6+ years of pharmaceutical, biopharmaceutical experience in Quality and/or Compliance (GxP) environment.
- Experience in SAP, Trackwise are strongly preferred.
- Application of quality risk management
- 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 knowledge of GxP requirements and regulations
- Good project management, planning and scheduling skills
- Good communication skills both verbal and written
- Good interpersonal skills and able to work with cross functional team collaboratively.