Job description

• Preparation of stability calendar for research samples and for pilot production samples.
• Preparation of protocols for stability testing.
• Managing stability samples: labeling stability samples, putting samples to stability chambers, withdrawal of samples at predefined stability points) and managing stability data.
• Preparation of stability reports.
• Estimation of shelf-life of drug products with the use of statistical software.
• Train other R&D personnel concerning Stability Topic.
• Write Stability SOP’s.
• Write stability part of the dossier.
• Follow SOP.

Job requirement

• At least 06 months to 01 year of relevant professional experience in stability management.
• Ability to writing stability protocols and reports according to ICH requirements.
• Ability to estimation of shelf life based on stability data of pilot productions.
• Ability to preparation of stability calendar for pilot production samples and research samples.
• Ability to have professional knowledge on: ICH stability requirements for drug products.
• Ability to estimate shelf-life for drug products.
• Ability to write stability protocols, reports and conclusions.
• Ability to write stability part of registration dossier.
• Ability to analyze and solve problems.
• Ability to work under pressure.
• Ability to work in team.
• Good command of English.

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