Quality Operations Supervisor (API)

About the role

AbbVie is looking for a Quality Operations Supervisor (API) in Singapore to supervise a team of API Quality Operations specialists. The role keeps AbbVie's quality systems in place for API manufacturing in line with company policies and cGMP, provides quality oversight across the API warehouse, QC, manufacturing, engineering and IT, and takes part in global quality coordination and continuous improvement.

Key responsibilities

• Supervise a team of Quality Operations Specialists, mentoring them and interns, and ensure quality goals and metrics are met
• Independently handle routine activities such as batch review, release, walkthroughs and tag-outs, and train colleagues on batch release and MES review
• Review and approve SOPs locally, and oversee batch record reviews and QA dispositions for API/BDS batches
• Lead investigations of non-compliance, including product impact assessments, root cause analysis and corrective and preventive actions
• Support change management, including change plan review, PQR reports and the site change coordinator role
• Lead New Product Introduction quality, product changeovers and process FMEA updates, and supervise the Annual Product Quality Review
• Participate in the global Quality COE and cross-functional improvement teams, and coach specialists on cGMP and quality systems

Required profile

• Bachelor's degree in a science, pharmacy or engineering field, or equivalent
• At least 6 years of relevant experience in a GxP environment within a quality function
• Proven track record of teamwork

Required skills

• Knowledge of quality and compliance management and of regulations affecting APIs
• Solid knowledge of GxP requirements
• Good decision-making, planning, scheduling and communication skills