SENIOR QUALITY OPERATIONS SPECIALIST

Job ID: R00129807

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.

Job Description

Purpose

The Senior Quality Operations Specialist assists site management to provide oversight on the quality system execution for the manufacturing and production areas at all times. The incumbent is required to observe, document, discuss, monitor and trend, and report quality adverse events related to the manufacturing of the product(s). 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.

This role is intended to support the Biologics manufacturing operations.

Key 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.

Qualifications

• Bachelor Degree in a Natural Sciences (i.e. Biology, Chemistry), Pharmacy, or Engineering
• 6+ years of related pharmaceutical experience, with biopharmaceutical experience in Quality and / or Compliance (GxP) environment
• Strong knowledge of quality / compliance management as well as regulations and standards affecting APIs / Biologics
• Experience in SAP, Trackwise strongly preferred
• Total commitment to quality and application of quality risk management
• Demonstrates the highest levels 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

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html