RD Stability Specialist At Orchdia pharmaceutical
Job Description
Executing analytical tests for all types of stability studies and stability plans, ensuring conformity to specifications till end of shelf life of the product following policies, standards and procedures and documenting analysis final results to stability files provided to local and foreign authorities.Participate in translating business goals into research and development objectives, plans, and deliverables.
Correlate the results of the performed trials and experiments and recommend any updates in procedures of stability so that optimal parameters can be achieved.
Report, document and summarize the results of experimental trials and other data into a format that allow easy review by superiors.
Follow up and control work flow to achieve objectives of stability with subordinates.
Participate in Preparation of new products stability files to be registered and launched onto the market in accordance with local regulatory requirements and requirements of export.
Execute plan of stability studies covering research and development trials, first three batches, process validation, and change or add supplier, change composition, ongoing and in-use stability study covering for all products.
Monitor of stability temperature and humidity and ensure of archiving them.
Prepare protocol for each stability studies containing summarized data and results.
Send stability samples for micro analysis (sterility or preservative effectiveness test) for long accelerated and in use.
Analyze of the new product under stability condition must meet the product specification especially impurities.
Send and follow up stability samples for external analysis e.g. eye irritation, particulate matter.
Create product files and necessary paperwork.
Create SOPs related to stability system and covering research and development activities.
Update SOPs related to stability system and covering research and development activities.
Report problems relating to products in stability chambers to research and development manager immediately.
Maintain and enhance capacity of stability chambers to cover different dosage form.
Work through, follow and adhere to safety instructions and requirements in research and development labs.
Work according to GLP, GMP and GDP rules.
Shall be consulted and participated in the EHS management system and its improvement elements via reporting actions / incidents those could occur or occurred and attend the relevant trainings.
Skills
Bachelor's degree in pharmaceutical science.From 1 to 3 years of technical experience in stability, analytical method validation and training preferably in the pharmaceutical industry.
Scientific, technical background in pharmaceuticals as well as cosmetics products is beneficial.
Using a basic knowledge of stability and basic knowledge in method validation techniques.
Excellent English, verbal / written communication.
Excellent computer skills.
High creativity and innovation.
Capable of communicating and working in a team environment.
Education
Pharmaceutical science
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