Qualified Person - QP

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.
• Support senior QA leadership through QP decision making to drive continuous improvement and compliance.

• 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 elevate 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 that complaints, deviations, and any significant quality incidents are thoroughly reviewed and closed out in a timely manner
• Ensure changes are appropriately managed
• Approval of procedures and policies
• Work as part of the Meira
  
  GTx team to undertake continuous improvement of business quality systems
• Advise and participate in projects from a quality assurance perspective
• Keep up to date with regulatory changes and developments, aiding the transition into company SOPs and processes
• Assist with regulatory inspections providing SME support. Assist in the remediation of regulatory findings and closure of deficiencies.
• Support self-inspection process, providing coaching to self-inspection auditors and review of the outcomes of audits
• Strong interpersonal skills must have the ability to establish and maintain effective working relationships with internal and external peers and stakeholders
• Experience of leading/participation in EU and US competent authority inspections

• Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures
• Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken
• Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions is closed timely and in a RFT state