Alejandro Ortega Muñoz Email & Phone Number

Santiago, Región Metropolitana De Santiago, Chile

• Ensure that all applicable local GMP regulated activities in Grünenthal Chile are based in the global Pharmaceutical Quality System of the Grünenthal group.• Ensure compliance with local legal/regulatory requirements and global standards and providing oversight to Global Commercial QA and the local Country/General Manager.• Support all the activities for the fulfilment of GMP activities leading by Technical Director in order to assure the quality, efficacy and safety of the GRT imported & CMO products in Chile.• Continuous support with the good practices, local key performance indicator reports impacting in the local business.

Cerrillos, Región Metropolitana De Santiago, Chile

Lead the Quality Assurance Area of a National Pharmaceutical Company, which has a Head count of 26 people who exercise different functions inside the company as Analysts, Technician, Engineers, Pharmacist, etc.Responsible of managing all the functions described in the Chilean’s regulatory code for pharmaceutical products and food for medical use (DS Nº 3), including:• Verify that the manufacturing of the pharmaceutical products are done according to cGMP and cGPL and supervise their compliance at all levels.• Ensure the proper establishment of data in each of the records that the company must maintain in accordance with current regulations.• Release each production lot (Batch) for distribution to the market.• Establish the validation programs for the manufacturing processes that may be responsible for causing variation in the characteristics of the products in process and finished products, and also for the analytical methodologies.• Establish and enforce the calibration and qualification programs of the equipment and instruments of the company.• Design and execute programs to verify the reliability of the methods used in the inspection and analysis of the quality attributes of materials and products.• Design and execute audits of suppliers and external service providers and self-inspection audits (process, facility and documentation).• Monitor and ensure the correct use of Quality Management Systems (Non-Conforming, Deviations, CAPA’s, etc.)• Coordinate the identification and investigation of quality related complaints coming from customers, identifying and resolving root causes• Exercise the other functions assigned by the local regulation, in relation to the professional activity throughout the company.

Santiago, Chile

Among the achievements obtained in this period are: • Manage, coordinate and oversee all validation studies, including: Utility Systems qualification (Compressed Air, Purified Water, and HVAC Systems), Cleaning Validation, Analytical Methods Validation and Manufacturing Process Validation.• Develop a Metrological Laboratory, which handled most of the calibrations required by the Company, meeting cGMP requirements. • Participation in a FAT (Factory Acceptance test) of an Automatic Liquid Filler Production Line at Tre Emme Srl Senago, Italy and at A.O.M S.p.a. Bologna, Italy.• Partner with Operations, Quality, and various functional areas on cGMP and cGLP implementation.• Conducts and participate in deviation investigations to identify root causes and define corrective and/or preventative actions (CAPA).• Participate in the creation and/or review of Standard Operating Procedures (SOPs) for systems, equipment, and projects• Lead projects for improvements of Purified Water, Compressed Air and HVAC Systems (Achieve clean room status).

Santiago Province, Chile

Participation and Experience in:• Bioequivalence• Research & Development (R&D) of products.• Process and Analytical Validations• Equipment Qualification

Pharmacist

Graduate with Honor in the year 2011.

Diplomado En Buenas Prácticas De Manufactura Vigentes, Con Énfasis En Auditorías, Distinción Máxima

Activities and Societies: Graduate with Honor in the year 2012.