Quality Operations Specialist II
On-siteSingapore, Singapore
Job Summary
Oversee quality system execution on manufacturing and production areas by observing, documenting, and reporting quality adverse events. Lead investigations into non-compliance in incoming materials, QC testing, and manufacturing processes to perform root cause analysis and implement corrective actions. Release incoming material and product batches while ensuring adherence to approved company policies and procedures. Conduct regular walk-throughs of manufacturing, engineering, and warehouse areas to maintain compliance standards. Champion continuous improvement through data trending, kaizen projects, and quality risk management activities. Serve as the site change coordinator, managing global change proposals and leading cross-functional risk assessments. Support new product introductions and annual product quality reviews to ensure the highest quality and compliance of released batches at the AbbVie Operations Singapore site.
Required Qualifications
- Bachelor Degree in a Sciences (i.e. Biology, Chemistry), Pharmacy, or Engineering
- knowledge of quality / compliance management as well as regulations and standards affecting APIs / Biologics
- Minimum of 3+ years of pharmaceutical, biopharmaceutical experience in Quality and/or Compliance (GxP) environment
- Good knowledge of GxP requirements and regulations
- 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 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
Desired Qualifications
- Experience in SAP, Trackwise are preferred
- Application of quality risk management
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