Senior Formulator
MS Pharma Injectables
Total des années d'expérience :9 years, 6 Mois
*Perform Pre-formulation studies.
*Preparation of literature surveys, COA for raw materials, specifications, method of analysis for new products.
*Raw materials, packaging materials, RLD samples receiving.
*Perform Formulation and process development for solutions and lyophilized drugs.
*Preparation of QTPP and Risk assesment reports.
*Perform modifications of formulation and assure conformity to specifications.
*Perform pilot and lab scale batches of new formulated dosage forms for stability purposes.
*Perform packaging with the required packaging materials for products.
*Commit to all documentation requirements for each formulated or reformulated products.
*Commit to implementation of GDP, GLP and GMP requirements within formulation department.
*Perform tasks related to process validation upon required.
*Equipment and tools verification/calibration following up.
*Pilot area cleanliness, environmental monitoring and sterilization following up.
*Perform Terminal and Aseptic product manufacturing.
*Perform a proper CIP and SIP for preparation mixers, and following up.
*Perform a filling process and stoppering processes using vials filling machine, pre filled syringes and infusion bags filling machine.
*Preparation of formulation, reformulation and pilot area related documents and SOP's.
*Apply SOP's in formulation department, dealing with equipment, calibration, maintenance, cleaning and safety.
*Perform Pre-formulation studies.
*Injectables drugs development.
*Perform pilot and lab scale batches of new formulated dosage forms for stability purposes.
*Perform packaging with the required packaging materials for products.
*Commit to all documentation requirements for each formulated or reformulated products.
*Commit to implementation of GDP, GLP and GMP requirements within formulation department.
*Perform Terminal and Aseptic product manufacturing.
*Perform a filling process and stoppering processes using vials filling machine, pre filled syringes and infusion bags filling machine.
Bachelor of Chemistry (2010-2014)-Grade (2.57/4) Good.