1.     A very good knowledge of pharmaceutical business and the legal requirements in this industry (Gamp5, Who, GXP)

2.     Extensive expertise regarding monitoring the performance and accurate and efficient supporting of pharmaceutical companies

3.     Special knowledge in designing and implementing software solutions in pharmaceutical, food and cosmetic industries

4.     Expertise in Computer System Validation (CSV)

5.     Designing and implementing manufacturing processes according to GXP requirements and the requirements related to each pharmaceutical factories

6.     Expertise in establishment IMS(ISO9001, 14001, OHSAS18001), including:

·        Integrated Management System of quality, environment, safety and health management

·        Method of Self-Inspection to prepare internal and external inspections to receive the license

7.     Expertise in editing and preparing documents

8.     Expertise in Qualification and GXP HVAC

9.     Expertise in qualification of production equipments

10.             Expertise in the method of using the information of production batch records and providing analytical statistics

11.            Ability of understanding qualitative processes and traceability based on our experience and expertise in controlled environments

12.             Ability and expertise in quality functions model

13.             Total awareness of production processes and providing the most efficient solutions

14.             Possibility of implementing and making changes according to the selected solution

15.             Required trainings to support system users

16.             Total awareness of analytical activities, considering the strategies and objectives of the factories

17.             Suggesting appropriate solutions according to software analyses

18.            Ability of perceiving process control, recognition and quality parameters in laboratory

19.             Ability to define control model and describing it in different fields of software including: raw material quality, product quality while manufacturing, stability quality of products

20.             Extensive expertise skill and knowledge in information systems of pharmaceutical and food industries

21.             Total awareness of production processes and controlling cost of offering the most efficient solutions

22.             Total expertise and knowledge regarding document requirements and supervisory control

23.            Investigation and controlling the evaluation of raw material suppliers

24.            Traceability of materials used in manufacturing processes