Production Manager
Hikma Pharmaceuticals
Total years of experience :19 years, 0 Months
-Managing sterile, non-sterile and potent production processes within the APIs Plant and providing necessary guidance to support various production phases.
-Responsible for day-to-day production operations within the Sterile, non-sterile and potent manufacturing plants
-Planning, scheduling, strategizing, and overseeing all sterile, non-sterile and potent production activities while continually building sales and maintaining profitability.
-Communicate effectively with the senior managements and the Production team, informing and updating them regularly to guarantee that production, sales, and production objectives are met.
-Establishing production schedules while ensuring that the flow of production processes and production rate within the APIs Plant is in compliance with monthly production plan.
-Ensuring that the safety, environmental and health regulations are being adopted and properly applied through various production processes and taking required actions in case of accidents.
-Coordinating with the APIs Plant supply chain functions to check conformity of raw material inventory and coordinating with suppliers regarding raw materials orders.
-Coordinating with the APIs Plant quality functions to ensure compliance of processes in various production phases with set quality standards as well as facilitating sampling activities and required inspections required to attain the approval on finished products.
-Following up internal, external and corporate regulatory inspections while ensuring proper replies and effective corrective/preventive actions (CAPA) are considered on timely basis.
-Conducting regular maintenance investigations to check/ensure efficiency of production machines at the APIs sterile, non-sterile and potent Plants functions as well as recommending CAPA’s, when the need arises.
-Coordinating with the APIs Plant Maintenance function to complete machines maintenance, setups and adjustments schedules.
-Coordinating and suggesting regarding scale-ups preparations with R&D function and drafting/approving the relevant manufacturing formulas.
-Purchasing production equipment, utensils, and tools and contacting the suppliers.
-Supervises, motivates, and supports the staff daily, applying a team approach and maintaining open communication.
-Providing required training to subordinates in order to guarantee compliance of production operations to proper procedures according to set SOPs.
-Developing solutions for potential hazardous situations in APIs Plant, in addition to coordinating with the responsible employees in identifying and handling these issues, and communicating concerns and requirements as required.
-Initiate hiring when needed to cope with expanding workload or for replacement of substandard employees.
Managing Hikma APIs RA activities and achievements; including annual targets, submission timelines, communicating with the FDA, EMEA, MENA and other regulatory agencies agents.
Preparing the necessary documents to be submitted to the regulatory agencies as Drug Master Files (DMF) in support of drug application that comply with the FDA and EMEA regulations, in addition to maintaining the subsequent annual reports and amendments.
Performing internal auditing and regulatory inspections while ensuring that Hikma standards, specifications, production and processes are in compliance with regulations.
Reviewing and approving Hikma APIs DMF related documents and processes.
Mass is a plastic manufacturing company produce PET performs for both water and CSD bottles which is accredited by COCA-COLA and PEPSI-COLA in accordance with GMP, ISO 9001 and the HACCP codex regulatory.
Representing “Mass” management against the PEPSI COLA, COCA COLA, ISO and HACCP accreditations committees.
Maintain the laboratory books and the quality control documents, such as control charts, proficiency testing, checking the results, signing the reports and certificates.
Follow up the laboratory instruments calibrations.
Conducting laboratory tests such as, raw material PET resin, colorant, melting (IV), finished dimensions, Acetaldehyde (AA) by HS GC-FID, ets.
During my work at RSS, i held the following positions:
- Analytical Chemist in the Organic Material division (Chromatography lab).
- Analytical Chemist in the Inorganic Material division.
- Deputy supervisor of Chromatography, Medical and Industrial gases units.
I was responsible for conducting the following duties:
•Prepare consultation, tests, and laboratory statistic draft reports.
•Prepare action plans and standard-operating procedures (SOPs) concerning both laboratory instruments and tests.
•Maintain the laboratory books and the quality control documents, such as control charts, proficiency testing, inter-laboratory comparison, checking the results, signing the reports and certificates according to GLP requirements, International standards protocols, ISO 9001 and ISO/IEC 17025.
•Follow up the laboratory instrument calibration, checks, troubleshooting and
maintenance programs.
•Providing specialized training courses for external trainees as well as the Universities students, such as Chromatographic analysis by HPLC or GC with troubleshooting, FTIR analysis and Food additives analysis.
•Conducting laboratory tests for the following materials: Pesticides formulations (Purity of A.I ‘’granular, EC, SL and SC’’, Stability tests, volume, solvent analysis, pH, Density and Bulk density according to CIPAC Handbooks), Chlorinated pesticides residues, Active ingredients in (Herbicides, Fungicides and Drug), Food analysis ( Antioxidants, Preservatives, Vitamins and aminoacids analysis according to AOAC methods of analysis), Polymer analysis, Solvent analysis, Medical and Industrial gases (O2, N2, Air, NO2, CO2 and CO), FertilizersCosmetics and Detergents, and others, in addition to administrating advanced analytical validation studies, project, and research topics by utilizing the classical analytical methods and the following instruments:
HPLC-PDA, HPLC-Fluorescence, GC-MS, GC-ECD, GC-NPD, GC-FID, GC-TCD, Aminoacids analyzer, and FTIR-Spectroscopy.
R&D Dept, Analytical validation Section
-Extensive analysis in order to validate and develop analytical methods according to USP, BP and EP protocols by using the following instruments HPLC (PDA, RI and EC), UV-Spectrophotometer, Dissolution tester, etc...
- Fellow up the GMP’s and GLP’s instructions.
- Full documentation of validation process.
M.Sc. Chemistry, Chemistry Dept, University of Jordan, Jordan Field: Industrial and Environmental Chemistry •Thesis Topic: "Assessment of Used Vegetable Oils Blended With Jordanian Diesel as Bio-Diesel Fuel" The assessment was achieved through physical and chemical measurements according to American standard test methods (ASTM) where it's as follows: Free fatty acids analysis by GC-FID, Calorific value by Bomb Calorimeter, Viscosity, Sulfur content by XRF sulfur analyzer, Nitrogen content, Flash point, Pour point, Cloud point, Density, Specific gravity and Water content. •Average 3.63 out of 4, with very good evaluation. •Teaching language is English.
Generla Chemistry Science - I ranked as the top student in my batch (81.44%) - First student honor