Marco Antonio Parada Gómez

Coordination in validation activities, personnel training related CMO unit operations, new documents issuance giving support to new company projects and CMO Department.

• CMO Validation

Validation CMO Coordinator supporting CMO Company Branch with the following activities:

• Coordination and execution of Annual Sterilization/aseptic plan with CMO Products (Medical Devices)
• Development of sterilization process (Steam In Place and Moist Heat Sterilization) for Company and CMO Products-
• Audit preparation/Support and Follow ups with Company Stakeholders and International Regulatory Entities.
• Support in company Quality System activities assigned on Validation Office or Multidisciplinary such as: CAPA, SCAR, Deviation, Product Complains, Investigations, and Change Controls using quality management system (TrackWise QMS).
• Validation Project Management (QP-PQ) with Company stakeholders.
• Factory Acceptance Tests (FAT)/Site Acceptance Tests (SAT) for new Stakeholders equipment.

Validation Coordinator supporting oral solutions department with the following activities:

• Validation Project Management ( QP-PQ)
• Coordination and execution of annual sterilization plan detached on Validation Master Plan.
• Development of sterilization process (Dry Heat, Steam In Place and Moist Heat Sterilization) for Company and CMO Products
• Support in Quality System activities detached Validation Office using quality management system (SAP)
• Factory Acceptance Tests (FAT)/Site Acceptance Tests (SAT) for company Equipment.

FDA Certification Project : Support as validation engineer following guidelines:

• CFR Title 21 part 11 , 210 computer Systems Validation
• CFR Title 21 part 10, 211 Current Good Manufacturing Practices for Finished Pharmaceutical products.

Support Operation Qualifications (OQ) & Performance Qualification (PQ) on company branches mainly supporting& production departments based In Tlajomulco Facilities such as: (Solutions In Bag, Plastic Ampoules, Injectable Powders, Lyophilization and Aseptic Processing).

• ISO 17665-1 Sterilization of Health Care Products part 1 (Requirement, development, validation and routine control of sterilization process for medical devices.
• USP 1229.1/1229.2 Steam Sterilization Direct Contact/Moist Heat Sterilization of Aqueous Liquids
• PDA Technical Report No.1 “Validation of Moist Heat Sterilization Process”
• NOM-059-SSA1-2015 Buenas Prácticas de Fabricación de medicamentos.
• INVIMA Resolución 1160 (2016 ) : Manuales de buenas prácticas de manufactura
• ISO 11138-1 :2006 Sterilization of Health Care Products /Biological Indicators Requirements
• ISO 13408-5 Aseptic processing of health care products

Support on new development products and stability studies (Shelf Life and Accelerate Shelf Life) of Sugar Confectionary Formulas and Flavored Milk through Physical/Chemical Analysis and data analysis of sensory evaluation tests in a 30 person panel to identify alternate suppliers, new formula developments.

• Design and development of analytical and descriptive testing with raw materials, ingredients, packaging and development/finished product.
• Descriptive Sensory Training to selected judges.
• Sensory Panel Implementation with company employees.
• PMCA Student Outreach Program (PA,USA)