Quality Assurance Specialist (Operations)
Current- Qualified to review completed batch records to ensure compliance with cGMP per written procedure- Timely response to customer’s concern on closed executed batch records- In depth awareness of media, buffer and upstream processes; identifying operational factors which influence the process- Involved in making real time decisions and preliminary investigation on process events on the shopfloor based on knowledge of defined SOPs- Conduct internal audits and… Show more - Qualified to review completed batch records to ensure compliance with cGMP per written procedure- Timely response to customer’s concern on closed executed batch records- In depth awareness of media, buffer and upstream processes; identifying operational factors which influence the process- Involved in making real time decisions and preliminary investigation on process events on the shopfloor based on knowledge of defined SOPs- Conduct internal audits and inspections of the plant to ensure compliance with quality standards and ensure CAPAs are initiated to addressed non-conformity- Qualified in compiling batch documentations for lot release within defined targets defined by review and release schedule- Qualified trainer for batch record review - Change agent in revision of SOPs ensuring SOPs are up to date with new workflow and documentation- Supported in the EAEU GMP audit as a backroom member Show less