Purpose
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, 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.
Qualification and experience
Qualifications
- Bachelor Degree in a Natural Sciences (i.e. Biology, Chemistry), Pharmacy, or Engineering.
Experience
- 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.
Skills
- Application of quality risk management.
- Total commitment to quality and maintain a high standard of work at all times.
- Demonstrates the highest level 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.
