Qualified Person - QP

Job description

Your mission: Purpose of Job - Undertake the duties and responsibilities of the Qualified Person as defined in Directives 2001/83/EC and 2001/20/EC. - Act as GMP Subject Matter Expert (SME) to facilitate site compliance with the company’s Quality Management system. - Ensure systems are identified and in place to maintain compliance with current established GxP standards. Job Description: - Support senior QA leadership through QP decision making to drive continuous improvement and compliance. Major Activities: - Ensure batches are manufactured and tested to GMP and in line with the CTA/IND and PSF - Review completed batch records and complete batch dispositions - Develop and own the batch release process - Provide QA oversight, technical QA expertise and leadership across all aspects of GMP Operations from Manufacturing, Tech Transfer through Warehouse activities, Engineering, Quality Control, Supply Chain and Operations support - Identify, communicate, and escalate quality and compliance risks. Provide direction for and participate in timely resolution, acting always with an appropriate sense of urgency. - Attend and participate in the Quality Management Review meetings - Ensure th...