Ibis Moreno

• Conducted thorough reviews of labeling content for accuracy and adherence to regulations.
• Recommended improvements to processes and Quality Management System.
• Stay updated on changes in regulations and applicable guidelines in CFR 210 & 211,21 CFR Part 201, and 21 CFR Part 314.80 y 314.81 for OTC/homeopathic drugs.
• Organizing and planning process validations, equipment, and critical systems qualifications.
• Review of protocols and reports.
• Developing and updating of SOPs related to Supplier audit and Qualification as well as Regulatory Affairs.

• Managed and motivated employees to be productive and engaged in work.
• Accomplished multiple tasks within established timeframes.
• Reviewed and pre-approved Deviations, Customer complaints, internal audits, and regulatory CAPA Plans.
• Recommended, developed and reviewed SOP´s.
• Scheduled and reviewed Performance Qualifications by third-party contractors for critical systems (HVAC and Compressed air).
• Managed Supplier deviation investigations and CAPA Plans for rejected supplies.
• Supervised instruments calibration program.
• Attended Internal and International GMP audits/Inspections (UL and FDA).
• Implemented and prepared Quality Agreements with suppliers.
• Prepared and Reviewed Process Validation, Equipment Qualifications and Holding time studies Protocols and Reports, Change Control System, and User Requirements.
• Company profile: Homeopathic drugs
• Customers: Walgreens, Walmart, HEB, CVS, Albertsons, Rite Aide, Fiesta.

• Provided leadership to Quality Assurance Inspectors
• Responsible for maintaining Document Control Procedures and Practices
• Prepared and updated QA-SOPs, Forms, Logs, Validation, Qualification Protocols, and Reports
• Distributed controlled copies of all newly issued and revised documents to the appropriate/relevant users and departments
• Elaborated Annual Product Reviews (APRs) for products marketed in U.S.
• Assisted in the review and approval of labeling.
• Managed User Requirements, Change Control System, and Internal and External Audits, as well as CAPA plan follow-up.
• Assisted in GMP International Audits as a translator, and to establish CAPA plans.

Company profile: Homeopathic drugs

Customers: Walgreens, Walmart, HEB, CVS, Albertsons, Rite Aide, Fiesta

• Provide technical assistance for customers' inquiries to comply with food and purified water regulations.
• Collection of purified water and food samples.
• Performed physico - chemical and microbiologic analysis
• Environmental monitoring in living (operator´s hands), and inert surfaces (equipment, walls, working tables).
• Followed Good Documentation Practice for food and purified water lab regulations.

• Provided support for efficient office operations in a construction company environment.
• Ensured all documents were up-to-date and accessible, and assist with creating electronic and physical document archives.
• Prepared and reviewed clients file for submission to Federal Institution for home mortgage.
• Managed client database.

• Supervised production line operations to comply with established SOPs.
• Managed and organized Quality Inspectors activities.
• Supervised Finished product warehouse Inventory Control and work orders fulfillment.
• Implemented electronic inventory control.

• Perform water sample collection and basic analysis to monitor parameters such as pH, turbidity, dissolved oxygen, and biological oxygen demand (BOD), suspended solids and Total solids.
• Assist in conducting chemical and biochemical tests on water samples to ensure compliance with quality standards.
• Use lab equipment to conduct routine tests and accurately document findings.
• Record, organize, and analyze data on water quality parameters, maintaining logs and generating reports for senior engineers.
• Follow all laboratory safety protocols, including proper handling and disposal of chemicals and waste.
• Ensure adherence to environmental regulations and standards set by local and federal authorities.