Quality Operations Specialist

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. 

Purpose

Quality Operations Specialist must always assist site management to oversight the quality system execution on the manufacturing and production areas.  Incumbent is required to observe, document, discuss, and report quality adverse events related to the manufacturing of the product.  QO Specialist is responsible to ensure highest quality and compliance of released batches at the AbbVie Operations Singapore, Tuas Singapore site. 

Job Responsibilities

• Ensure that products manufactured at AbbVie Operations Singapore meet approved company policies, process and procedures.
• Participating in investigations arising out of product or manufacturing processes non-compliance.
• Review of completed Batch Records.
• Review of Manufacturing Logs as required.
• Support product changeover/ line clearance activities as required.
• Provide quality oversight support to manufacturing, engineering, QC laboratory and supply chain as required. Administration of Quality Logs, e.g. QA Hold, QA tag out
• Perform regular walk-thru of manufacturing areas as required. Proactively seek to improve and simplify site processes and procedure, specifically relating to the Operations function to ensure compliance is always maintained

Job Requirements

Education

• Bachelor’s 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 always maintains a high standard of work
• 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

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.