Cindy Hazel Email and Phone Number

QA• Directly reporting to the General Manager• Ensures that the product an organization provides is fit on purpose, is consistent and meets both external and internal requirements. This includes customer expectations.• Coordinates the activity required to meet quality standards.• Monitors and advise on the performance of the quality management system, produce data and report on performance, measuring against set standards.• Liases with other managers and staff throughout the organization to ensure that the quality system is functioning properly.• Advises on changes and their implementation and provides trainings, tools and techniques to enable others to achieve qualityREGULATORY• Directly reporting to the General Manager• Manages the Regulatory Department and develop processes so that new chemical entities so that new dosage forms and new indications are registered in a timely fashion.

• Attends in the renewal of government licenses (LTO with FDA)• Performs liaison work with government agencies such as the following:a. Food and Drug Administration (FDA)b. Department of Health (DOH)c. Intellectual Property Office (IPO)d. Philippine Drug Enforcement Agency (PDEA)• Directly responsible for the initial registration of new products as well as renewal of existing products• Canvasses raw materials requirement of the company• Performs liaison work with drug manufacturers and raw materials suppliers • Oversees the distribution and storage of pharmaceuticals raw materials and packaging materials in the manufacturer’s warehouse• Checks that pharmaceutical products are batched certified prior to marketing distribution• Maintains arrangement of records regarding products documentation• Visits manufacturing establishments on a periodic basis• Product Forecast, P.O. raw materials, packaging materials and request a Job Order to Manufacturer both local and international.• Product Costing• Royalty Fee Computation.• Coordinates with manufacturer and suppliers for the delivery and importation of raw materials and finished product.• Conducts training on product knowledge to the newly hired Medical Representative.• Conducts training on product knowledge for the new products to the Sales Department• Introduce products to the Hospital Therapeutic Committee• In-charge of handling prescription orders, medical certificates and other requested documents by doctors and hospitals.• Prepares the necessary documents for drug accreditation to hospitals and other medical establishments.• Other tasks as deemed necessary by management