Davipharm

Job description:

– Preparation of specifications and development of analytical methods for testing new products, new APIs and intermediates
– Preparation of protocols for method validation
– Conducting tests for analytical method validation based on the protocol
– Preparation of analytical method validation report
– Testing of research samples of drug product according to stability protocol, new APIs and intermediates
– Reporting the results
– Performance of dissolution profiles for in vitro dissolution study and preparation of in-vitro study report
– Cooperation with formulation team and other departments to investigate causes of the deviation
– Preparation of protocol for transfer of new specification and analytical method procedure to Quality Control department
– Update of unsuitable analytical procedures. Find reasons and conduct to re-evaluation. (for QA system and reregistration)
– Train other R&D personel (how to operate equipment in the laboratory, how to work according to SOPs)
– Maintenance of laboratory equipment, standards, columns
– Write quality part of the dossier
– Works in safe, tidy way, keeps order in Laboratory and does other tasks requested by R&D Analytical Leader
– Follow SOP

Job requirement:

– Bachelor’s degree or higher degree from Pharmacy, Chemistry or similar
– At least 2 years of relevant professional experience in analytical R&D department in pharmaceutical industry or quality control department of pharmaceutical products
– Have professional knowledge on development and analysis of drug products
– Be able to analyze samples by analytical techniques like HPLC, UV-Vis, dissolution tester and others. Has knowledge of validation of analytical methods and development of analytical methods (preferably experience with taking care of equipment in analytical laboratory)
– Be able to write quality part of registration dossier
– Ability to analyze and solve problems
– Ability to work under pressure
– Ability to work in team
– Good command of English
– Be responsible, honest
– MS Office: Microsoft Excel, Word

Please contact our Recruiter or apply via email recruitment@davipharm.info