• Conceptual and detailed design for Solid, Liquids, Semi-Solids and Sterile production plants as per cGMP.• Solid, Liquids, Semi-Solids and Sterile production machines URS, sourcing, comparison, and selection.• Selection & development of primary & secondary packaging materials.• Design and selection of QC chemical & micro labs.• Technology transfer for all dosage forms (Manufacturing/ Analytical method/ Registration).• Preparation product BMRs, Manufacturing Instructions, BOMs, Process Flow Chartsfor all sterile products (Vial, Ampoule, Lyophilized) Aseptic and Terminal.• Preparation and Execution of Process Validation protocols including all CPPs andCQAs according to the cGMP.• Process Validation design and implementation.• Development of sterile products manufacturing processes, sterilization cycles andlyophilization cycles using corresponding PATs and instruments.• Sterile manufacturing process troubleshooting (vials, ampoules, lyophilized).• Product investigations (Stability data interpretation, failures, risks, reporting).• Scale-up of production batches (size, machinery, processes).• In charge for the pilot plant (Manufacturing to stability incubation and registrationsamples submission).• Filter validation, filter sizing for scale up and filterability studies.• Product compatibility, dilution and In-use studies.• GAP analysis for multiple production areas to meet the latest regulations and requirements.• CAPEX and OPEX for the pilot plant (new machinery, consumables, tools…etc.).• Team leader in the project rebuild managing Tabuk team responsible for the facilityrecovery in (Epoxy works, Panels/ walls/ covings replacement, plant disinfection, technicalcleaning for machinery).• Participation in Media fills (arrangement, interventions, fumigations, VHP, movement).• Manufacturing and validation of liquid orals sand semi-solids.• Analytical research (Stability, AMV, TAP).• Handling of CCRs, Deviations, CAPA and RCA.• Sterile machinery outsourcing and URS from manufacturing perspective.• SAT and commissioning for Large scale, Pilot scale and small scale freeze dryers.