What are the responsibilities and job description for the Lead Specialist - QA Operations position at EPM Scientific?
Lead QA Specialist - Operations
A global industry pharmaceutical leader with commercial products available across multiple therapeutic areas is seeking an experience Lead QA Specialist to take a key position in their Quality Assurance organization. You will be supporting the development of trusted medicines and continuing to advance innovative and sustainable solutions.
Key responsibilities :
- Engage in the training and development of QA team members, including Specialists, Senior Specialists, and Supervisors, focusing on QA Operations functions and GMP regulations.
- Lead and participate in quality improvement initiatives and cross-functional teams, offering QA insights. Assist management with strategic planning for intermediate batch record review / release, finished product batch record review, and other QA Specialist floor operations.
- Supervise the evaluation and triage of events, deviations, and unplanned maintenance activities by QA Specialists. Oversee the On-Hold material program, mentoring QA team members in monitoring and disposition of material.
- Conduct QA review and approval of controlled documents, written procedures, protocols, and MES recipes as required. Compile and provide information for inclusion in monthly quality metric reports.
- Ensure deviations are appropriately reported and participate in investigations of deviations as required. Support the review and approval of Trackwise® incidents related to manufacturing operations. Identify and implement continuous improvements for the elements of the quality system related to manufacturing operations.
Qualifications :
