Stability Analyst At Jamjoom Pharma
.jpg "Stability Analyst At Jamjoom Pharma")
Location: El Obour, Al Qalyubiyah, Egypt
Job description
Jamjoom Pharma has in a very short span of time emerged, as one of the leading pharmaceutical companies in the Afrasia region. The geographical focus of the company is on countries in the Middle East, Africa, and CIS regions. Strategic focus on selected therapeutic categories has contributed to the rapid growth, market acceptance, and overall success of the company.
Responsibilities
Analyze finished stability samples including (Solid, semisolid, Ophthalmic solutions) dosage forms.
Contribution to analytical method transfer according to approved protocols and specifications.
Perform and maintain GLP, GMP, and safety regulations in QC / Stability Department and ensure good handling and proper operation of laboratory instruments.
Notify QC / stability manager about any OOS/OOT occurrences and proceed in analytical investigation process.
Ensure proper detection, investigation and reporting of any failed QC / Stability results to relevant stake holders (QA, Regulatory, Quality Head, etc.….).
Prepare stability protocols for new trial batches, validation batches and production batches.
Prepare, Update SOP’s related to QC / Stability Department.
Prepare, Update Method of Analysis, Stability Analytical Worksheets of finished products.
Prepare weekly stability samples plans in coordination with Stability manager and follow up on it with the Stability technician.
Prepare, standardize and maintain availability of reference standard, volumetric solutions, glassware, and reagents and ensure their good handling and storage according to the approved SOP’s.
Assist in preparation of stability studies for all products manufactured in the site in response to regulatory authority (EDA) stability requirements for Variation, Registration or RE-registration purposes.
Ensure good housekeeping in the analytical lab, stability stores areas.
Assist in preparation of stability annual review report with stability manager at the end of each year.
Qualifications
Bachelor's degree in pharmaceutical science or Science.
At least 3 years of experience in QC / Stability in the pharmaceutical industry.
Good analytical and instrumentation background.
Good knowledge of DI, GDocP, cGMP, GLP safety regulation and EDA regulatory guidelines.
Good technical experience in analytical testing with its related aspects.
Familiar with global Pharmacopeias (Ex. USP, BP, EP, … etc.).
Good command of MS office.
Good English language and good computer skills.