Evaluation and monitoring of manufacturers and suppliers of active pharmaceutical ingredients.

Organization and participation in all activities related to manufacturers, audits and investigations, including: coordination, scheduling, conducting audits and checking responses to audits, monitoring the implementation of the CAPA plan.

Organization and participation in all activities related to the Quality Agreement, including: coordination of the Agreement within the company, coordination with the manufacturer, conclusion of Quality agreements with API manufacturers.

Organization and participation in all activities related to the assessment and approval of API manufacturers, request and evaluation of materials in accordance with GMP requirements.

Preparation of Module 3 for submission to state authorities. Preparation of documentation for the introduction of alternative manufacturers. Maintaining internal document flow, correspondence, Expertise of DMF.

Quality control of substances and finished products.

Work with analytical documentation, documentation manufacturers of API. Work with EP, BP, USP.

Quality control of finished products, substances. Work with analytical documentation, documentation of manufacturers of API. Work with EP, BP, USP.

Quality control of food, water and air.

Quality control of finished products, substances.