LILIANA SOLUCH

Managed Quality Management System (QMS) activities to ensure regulatory compliance.

Oversaw deviations, CAPAs, change controls, and document control processes.

Developed and implemented global procedures to standardize quality processes.

Collaborated with global teams to align quality standards across all regions.

Coordinated global quality projects, ensuring consistent application of standards.

Analysed new regulations to maintain compliance across all regions.

Upgraded Board of Health protocols to enhance compliance and productivity across global markets.

Supported quality assurance and operational teams, facilitating timely regulatory documentation submissions.

Drove improvements in operational efficiencies, resulting in effective global market operations.

Completed critical processing aids, streamlining workflows and boosting coordination among global teams.

Ensured efficient completion of all regulatory tasks while aligning with market needs.

Generated and managed Board of Health protocol submissions for regulatory bodies including OMCL/CBER in EU, China, and Mexico.

Conducted comprehensive data reviews to ensure product batch compliance with specifications.

Updated and reviewed QA documentation, including SOPs, forms, and specifications regularly.

Performed Raw materials and Critical Processing Aids review and release in SAP,

Executed samples preparation, capping, and filling for efficient production line setup.

Supported quality control and quality assurance activities to maintain compliance.

Managed equipment and storage area to optimize workflow and organization.

Archived GMP documents according to regulatory requirements for traceability.

Trained in Good Manufacturing Practices environment to uphold industry standards.