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About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Quality Operations Specialist

Singapore, , Singapore Req ID 2210734 Category Quality Assurance Division AbbVie
  • Ensure that products manufactured at AbbVie Operations Singapore meet approved company policies, processes and procedures.
  • Provide quality oversight of GMP manufacturing and manufacturing support, including technical operations, engineering, QC laboratory and supply chain activities.
  • Review 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.
  • Participate in investigations arising out of non-compliance in incoming materials, QC testing, manufacturing processes, warehousing, and product.
  • Participate in change management, including change coordinator and/or QA oversight roles to ensure change plan is managed and complies with applicable policies.
  • Perform regular walk-thru of manufacturing, engineering, warehouse and QC areas as required to ensure compliance is maintained at all times.
  • Participate and support new product introduction, operation excellence projects and other tasks as assigned by management.

Education

  •  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 2+ years of pharmaceutical, biopharmaceutical experience in Quality and/or Compliance (GxP) environment.
  • Experience in SAP, Trackwise are preferred.

Skills

  • 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 knowledge of GxP requirements and regulations
  • Good planning and scheduling skills
  • Good communication skills both verbal and written
  • Good interpersonal skills
Travel: No
Job Type: Experienced
Schedule: Full-time
ABBVIE

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