AbbVie Senior Quality Operations Specialist in Singapore, Singapore

Senior Quality Operations Specialist

Singapore, Central Singapore, Singapore

Quality Assurance

Requisition #1803413

Purpose Statement:

Senior 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, monitor and trend, and report quality adverse events related to the manufacturing of the product. Incumbent is required to lead and champion quality system improvement projects. QO Specialist is responsible to ensure highest quality and compliance of released batches at the AbbVie Operations Singapore, Tuas Singapore site.

Responsibilities:

  • Ensure that products manufactured at AbbVie Operations Singapore meet approved company policies, process and procedures.

  • Lead and provide guidance in investigations arising out of product or manufacturing processes non-compliance to perform root cause analysis and identify effective corrective action and preventive action.

  • Being the trainer and subject matter expert of exception management system and/ or batch release and/ or MES.

  • Review/Audit of completed Batch Record/MES and release API/BDS in accordance to release requirements.

  • Completion of Incoming Raw Material checks and release.

  • Perform periodic walk-around of manufacturing areas as required 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.

  • 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 and Biologics.

  • Minimum of 8+ years of pharmaceutical, biopharmaceutical experience in Quality and/orCompliance (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.

  • To be based in Tuas.