R&D Analyst

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 personnel (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 3 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.
• 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
• MS Office: Microsoft Excel, Word
• Good command of English
• Be responsible, honest.

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