Aura Elena Pérez Moreno

• -Led the EU GMP inspection readiness project, achieving 100% completion of identified compliance gaps prior to the audit.
• - Improved analytical laboratory productivity by 30% through the implementation of an Operational Excellence program, optimizing workflows, laboratory capacity, resource allocation, and process performance while fostering a culture of continuous improvement.
• - Increased the Great Place to Work® (GPTW) Trust Index by 40%, achieving a final score of 82% and contributing to the laboratory's Great Place to Work® Certification.
• Managed physicochemical and microbiological quality control labs, ensuring quality standards for incoming materials.
• Led a team of 20 across incoming and finished goods testing.
• Maintained GMP and GLP compliance while supporting timely raw material release.
• Prepared finished product and in-process testing workflows for laboratory use.
• Prepared quality control laboratories for EU regulatory inspections and audits.
• Coordinated microbiology laboratory coverage to maintain critical testing continuity and regulatory compliance.
• Monitored water analysis and critical utility systems testing schedules.
• Ran microbiology testing for raw materials and finished product verification.
• Managed laboratory teams through performance reviews and workload allocation, enhancing technical coaching and team development.
• Developed laboratory capability across accepted analytical methods and procedures.
• Drove laboratory optimisation tasks for efficiency, data integrity, robustness.

Managed equipment, consumables, and reference standards availability for operations.

Coordinated audit readiness and cross-functional actions for consistent product quality.

Supported timely manufacturing release decisions for supply chain needs.

Highlighted significant contributions and accomplishments within the role.

• Implemented excellence strategies, optimising analytical processes to meet industry standards.
• Led continuous improvement projects in quality control, enhancing process reliability and compliance.
• Developed and monitored KPIs to track efficiency and compliance.
• Coordinated cross-functional teams for quality initiatives, fostering collaboration and achieving project goals.
• Managed process optimization and digital transformation projects.

Interim Manufacturing Manager – Solid and Semi-solid Hormonal Pharmaceutical Products

• Supervised OEE and key manufacturing KPIs to enhance operational efficiency.
• Planned monthly hormone manufacturing output to meet targets and supply needs.
• Conducted GMP deviation investigations to identify compliance issues. with timely root-cause analysis and CAPA readiness.
• Analyse recurring failures and defects to drive corrective and preventive actions.
• Supported regulatory and internal audits by promptly addressing quality findings.

• Lead GMP and process control projects in the manufacturing area: 100% RFT, data integrity projects, batch record improvement, IPC software implementation.
• Led GMP and process specialist team, overseeing OOS, OOT, deviations, CAPA, change control, and training to ensure compliance and quality in manufacturing.
• Provided technical support for defect management during production processes, facilitating timely resolutions and minimising disruptions.
• Conducted risk assessments to implement new processes using both proactive and retrospective approaches.
• Led documentary team in manufacturing area, managing logbook and batch record generation to maintain accurate documentation and support regulatory requirements.

• Managed documentary team in quality control area, generating certificates of analysis, updating analytical work instructions, revising standard procedures, and implementing quality control training programme.
• Oversaw team addressing out-of-specification and out-of-trend deviations, ensuring compliance with quality standards.
• Supervised stability studies team, ensuring accurate monitoring of product shelf life to maintain quality assurance.
• Manage analytical method validation team and analytical transfers.

• Administer analytical method validation for raw materials and finished products.
• Create annual programme for analytical method validation and validated-state evaluation.
• Evaluate life cycle performance of analytical methods across validation phases.
• Establish KPI targets to monitor progress of validation programme.
• Streamline analytical method workflow for OOS detection and PQR support.
• Coordinate daily activities for validation analysts and documentary analysts.
• Plan and lead analytical method development using transmission Raman spectroscopy.

• Defined and tracked KPI targets for raw material quality control to ensure compliance and enhance quality standards.
• Investigated OOS results and managed quality deviations for raw materials QC, ensuring timely resolution and adherence to quality protocols.
• Maintain GMP compliance across physicochemical testing of raw materials.
• Plan raw material sampling activities using daily timetables and task lists.
• Provide real-time supervision and technical support to chemists and analysts.
• Monitored raw materials analytical productivity and supported continuous process improvements to optimise testing workflows.
• Review validation protocols and reports for raw material analytical methods.
• Review and update raw material analytical methods, resolving method issues.
• Implement and follow up CAPA actions from routine findings and OOS.

• Performed root cause analyses for GMP-compliant investigations, contributing to resolution of quality discrepancies.
• Analysed out-of-trend and out-of-expectation outcomes with structured tools, identifying potential quality issues.
• Investigated daily out-of-specification results in quality control laboratory, ensuring compliance and quality assurance.

• Supervised analytical method validation area, managing team of 8 analysts to ensure compliance with regulatory standards.
• Planned validation assignments and monitored activities in real time, aligning with VMP priorities to enhance project delivery.
• Reviewed validated parameter results, protocols, and draft validation reports to ensure accuracy and adherence to quality standards.

• Developed analytical methods validation for active pharmaceutical ingredients, ensuring compliance and reliability in drug product quality.
• Performed verification and validation of analytical methods during development implementation, contributing to regulatory adherence and data integrity.
• Acquired extensive hands-on experience with various instrumental analytical techniques. with instrumental analytical techniques. including: HPLC-UV, HPLC-DAD, UV-Vis, GC-FID, KF, and FTIR.

Conducted cleaning validation and trace analysis studies, utilising approved workflows to ensure accurate results and maintain operational standards.

• Conduct technical evaluations to develop new polymer grades for polypropylene output.
• Optimise and develop analytical techniques for catalyst additives evaluation in Polypropylene (PP) production.
• Perform instrumental analysis using HPLC-UV, HPLC-MS, GC-FID, GC-TCD, UV-Vis, and FTIR.
• Executed testing improvements to enhance technical department reliability and ensure timely reporting.
• Verify and calibrate laboratory equipment to keep measurements accurate daily.
• Develop and implement ISO 9001-compliant procedures across laboratory activities.
• Handled customer complaints by providing technical support and preparing specialised analyses and reports.
• Delivered technical training and provided on-site guidance to laboratory and process teams.