Quality Operations Specialist II

AbbVie; Singapore; On-site; SGD 80,000 - 110,000; Full time

Job summary

AbbVie Singapore is seeking a Quality Operations Specialist to support site management in overseeing the quality system across manufacturing and production areas. The role requires documenting, monitoring, and reporting quality issues, leading quality improvement projects, and ensuring released batches meet regulatory and company standards.

You will perform audits of incoming materials, execute QA holds, release batches, and drive data trending and kaizen initiatives with cross-functional teams.

Qualifications

• Minimum 3+ years of pharmaceutical quality/compliance experience.
• 0
• Knowledge of quality systems and regulatory requirements (GxP).
• Experience with SAP and TrackWise is preferred.
• Strong documentation and data-trending abilities.
• Excellent communication and cross-functional collaboration.

Responsibilities

• Ensure AbbVie Singapore products meet policies and procedures.
• Oversee incoming materials quality and processes.
• Lead investigations into non-compliance and implement CAPA.
• Perform QA data trending and Kaizen for improvements.
• Coordinate change management and cross-functional risk assessments.
• Release batches and conduct quality reviews.
• Conduct regular walk-throughs to ensure ongoing compliance.
• Assist site management in quality system execution.

Skills

Quality systems

GxP compliance

Root cause analysis

Process improvement Kaizen

Change management

Data trending

Project management

Cross-functional teamwork

Communication skills

Education

Bachelor Degree in Sciences

Tools

SAP

TrackWise

Job 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com . Follow @abbvie onLinkedIn, Facebook ,Instagram ,X andYouTube.

Job Description

Purpose Statement: The Quality Operations Specialist must assist site management to oversight the quality system execution on the manufacturing and production areas at all times. Incumbent is required to observe, document, discuss, monitor and trend, and report quality adverse events related to the manufacturing of the product. 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.

• 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 Sciences (i.e. Biology, Chemistry), Pharmacy, or Engineering.
• This position requires 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.
• Experience in SAP, Trackwise are preferred.
• Application of quality risk management
• 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 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.

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