Lucia Sanjuan

Assist with batch record and data review for approval and manage deviations for timely product release.

Support regulatory inspections and internal/external audits effectively.

Facilitate vendor management system qualification of external vendors.

Support activities at CDMOs ensuring compliance with cGMP.

• Managed and executed quality investigations, including conducting thorough root cause analysis, overseeing change control processes, and implementing corrective and preventive actions (CAPAs) to drive continuous improvement and ensure compliance with standards.
• Played a key role in developing and implementing eQMS system (MasterControl), improving document retrieval efficiency.
• Played a key role in assisting various companies to the successful acquisition of the Manufacturing Import Authorization (MIA).
• Led internal and external regulatory inspections (including MHRA), providing comprehensive support and achieving 100% compliance.
• Supported validation activities.
• Tracked quality metrics and implemented strategies to address underperforming areas.

• Managed QMS in a multi-product and multi-occupancy.
• Provided training to promote personnel development.
• Presented quality metrics and analysed data to identify underperforming areas.
• Worked with cross-functional teams to evaluate and implement quality initiatives.

• Supported internal and external regulatory inspections
• Worked with internal teams to evaluate and implement quality initiatives.
• Evaluated established processes to determine root cause of non-conformance.

• Handled samples in line with strict laboratory procedures using appropriate PPE.
• Processed samples, labelled containers and completed required paperwork.
• Conducted laboratory investigations.
• Performed laboratory testing in controlled conditions for reliable outcomes.
• Maintained laboratory equipment, limiting experiment disruptions.

• Performed aseptic manufacturing in Grade A
• Conducted isolator sterility testing
• Stored drugs in line with temperature and security requirements.
• Prepared production documents such as standard operating procedures, manufacturing batch records, inventory reports, or productivity reports.

• Agents group coordination and workspace management

• Performed HPLC analysis
• Responsible for equipment calibration.

• Carried out routine housekeeping to maintain safe and clean work environment.
• Adopted aseptic techniques to maintain sample integrity.