QA Manager (Pharma)

• Overseeing and coordination of QA team responsible for the oversight of manufacturing, packaging/labeling, QC laboratory, and plant maintenance / engineering
• Providing oversight of manufacturing unit operations and establishing metrics to track and trend operations, as necessary
• Initiates and/or performs deviation investigations for quality/compliance related matters and partners with site members and leadership to bring issues to timely closure
• Support technical transfer of new products. This includes supporting the validation, process development, procedures, specifications, and transition from validation to commercial stages
• Handle product quality complaints within the allowed timelines
• Write, review and approve quality SOPs to ensure cGMP compliance as required. Oversee the periodic review for any SOPs associated with the job function
• Review and approve cross functional SOPs on behalf of Quality
• Provide leadership within the organization for activities including but not limited to the Change Control Review Board, projects, operational excellence, etc
• Ensure an effective system is in place for the management of returned goods
• Ensure effective implementation of CAPAs arising from audits and complaints
• Manage the content and delivery of GMP training on site
• Participate in management reviews of process performance, product quality and of the quality management system to identify and action opportunities for continual improvement

• Degree level qualification in a scientific or relevant discipline
• Minimum of 5 years’ experience in a Quality department within the Pharmaceutical Industry and at least 2 years’ experience in supervisory role
• Strong communication, organization and people management skills
• Fluency in English both written and oral

LMW