Quality Operations Specialist II

One Stop Engineering; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

AbbVie Operations Singapore seeks a Quality Operations Specialist to ensure quality system execution across manufacturing and production areas at Tuas site. You will lead investigations, trend data, and drive kaizen for continuous improvement while ensuring released batches meet regulatory standards.

The role requires a Bachelor Degree in Sciences/Pharmacy/Engineering with 3+ years in quality/compliance (GxP), and experience with SAP or TrackWise is preferred.

Qualifications

• Bachelor Degree in sciences, pharmacy or engineering.
• Minimum 3+ years of pharmaceutical/biopharmaceutical quality/compliance (GxP) experience.
• Knowledge of quality/regulatory requirements for APIs/biologics.
• Experience with SAP or TrackWise preferred.
• Application of quality risk management.
• Strong commitment to quality and high work standards.
• Demonstrates integrity and strong work ethic.
• Good knowledge of GxP requirements and regulations.
• Strong project management, planning and scheduling skills.
• Excellent verbal and written communication.
• Good interpersonal skills and cross-functional collaboration.

Responsibilities

• Assist site management to oversee quality system execution in manufacturing areas.
• Observe, document, monitor, trend and report quality adverse events.
• Lead and champion quality system improvement projects.
• Release incoming materials, processes and product batches.
• Perform regular audits of inspection packages, batch records and manufacturing logs.
• Support Annual Product Quality Review and Product Quality Assurance.
• Perform data trending and drive kaizen in respective areas.
• Lead change management activities and cross-functional risk assessments.

Skills

Quality/compliance management

GxP knowledge

Quality risk management

Project management

Communication skills

Interpersonal skills

Education

Bachelor Degree in Sciences/Pharmacy/Engineering

Tools

SAP

TrackWise

Job description

Job Description

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