Quality Operations Specialist

4 weeks ago

Singapore AbbVie Full time

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

Purpose

  • Assist site management to oversight the quality system execution on the manufacturing and production areas at all times.

  • Observe, document, discuss, and report quality adverse events related to the manufacturing of the product.

  • 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.

  • 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.

Qualifications

Education

  • Bachelor Degree in a Natural Sciences (i.e. Biology, Chemistry), Pharmacy, or Engineering.

    Experience

  • 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.

Additional Information

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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