Experience

Med City Pharma

• Saudi Arabia
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Unit Senior Manger

  • Apr 2023 - Present

  Ensure all employees are following the cGMP standards, guidelines and quality policy that promote customer satisfaction.Perform root-cause analysis, and other problem-solving activities to identify and assure that the effectiveness of preventive actions rather than corrective actions are implemented. Manage, control and keep track of changes to quality regulations and guidelines.Manage and monitor the validation master plan and related validation tasks (IQ, OQand PQ) for production, laboratory and other related support services. Driving plant quality strategy and setting quality objectives for the plant in line with organization corporate goals.Driving continuous improvement programs at both product quality and plant system levels.Ensure the effective management of the organization quality systems.Lead a highly motivated, trained and developed staff in achieving business objectives.Help preserve organization’s reputation by ensuring that the organization products and services are capable to drive sustainable growth.Lead & Rollout Process Capability initiatives at sites, and support identifying and rolling out additional quality tools that align with delivery of quality objectives.Ensuring compliance with national and international quality standards including SFDA, USFDA. EMEA, ICH.., .Etc. and ISO systems.Build strong value-adding relationships with customers, suppliers and cross functional departments.Final approval for all starting material, packaging material and technical agreement in case of out-sourcing activities and any change in building, production line and product formula.Approve periodic assessment for quality system and ensure continuous improvement plan.Responsible for recall, complaints and coordination with concerned department to ensure corrective action implementation.Share, manage and follow technology transfer of drug product and the related registrations. Show less

• Acting Quality manager

  • Jan 2022 - Apr 2023

  In Charge for Quality Unit in Med city pharma

• Quality Control Manager

  • Oct 2020 - Jan 2022

  Management of the Quality Control laboratory ensuring compliance with cGMP regulations and guidelines as defined by FDA, ICH and internal approved SOP'sManage the analytical method transfer programs to support new productintroductions by ensuring accurate analytical procedures are established for routine use in the QC Laboratories.Manage the development and implementation of new automation, analyticalmethodology and instrumentation to expand capabilities, increase laboratoryefficiency, improve data quality and reduce costs.Manage personnel reporting to the position to effectively develop, recruit, train,evaluate, motivate, delegate and monitor their work.Monitors laboratory resources, identifies/reports resource gaps, and assists in recruiting, screening, procuring, and/or qualifying needed resources.Develop analytical staff to ensure accurate and reliable data are generated to complywith Quality programs and SFDA requirements.Manage and develop program for release testing of finished product, in-process,stability, and cleaning verification.Transfer finished product methods and ensure compliance with SFDA, EMDevelop and implement training and career development programs; conductemployee assessments including hiring, terminations, and promotions.Represent the department during audits, meetings, and teleconferences regardingtechnical and analytical issues with key regulators as well as internal and externalstakeholders.Provide responses to SFDA deficiency letters and audit observations.Manage Contract Test Labs for outsourced testing.Participate in multi-department team to implement ERP system (for areas such as:Warehouse, Procurement, QC, Manufacturing, and QA). Participate effectively in quality systems investigations, quality incidents, and OOS's.Issue monthly and technical reports as required.Manage personnel and fiscal budgets of the QC department.Establish and implement a KPIs structure to ensure optimal test and cost ratio. Show less



Tabuk Pharmaceuticals Manufacturing Company

• Saudi Arabia
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Control Section Head

  • Aug 2013 - Oct 2020

  1-Checking and giving approval for stability samples. 2- Prepare and Review the OOS, OOT, deviation and incident reports. 3- Preparing and reviewing method of analysis, certificate of analysis and standard operating procedure (SOP) enter the QC department. 4- Work on a SAP system. 5- Plan and distributed the daily routine work and day to day activities. 6- Perform continues internal auditing on Quality Control system to assure compliance with cGMPs, GLPs safety requirements and other quality control activities. 7- Follow up on analytical trouble shooting 8- Prepare stability protocol sheet and stability data sheet. 9- Follow up the proper archiving of stability data. 10- Supply regulatory affairs and Registration with stability data. 11- Check the qualification and re-qualification for stability chambers. 12- Follow up stability batches in the plants. 13- Follow up quality control maintenance issue with maintenance department. 14- Follow up supplier's offers for all Quality Control Tools and instruments. 15- Prepare department KPIs 16- Prepare Internal Order and yearly budget. 17- Coordinate with outside laboratories. 18- Audit preparation and related document. 19- Review Validation and Method technology transfer protocols and reports.. 20- Follow up daily and weekly data logger and charts for stability chambers. Show less



Hikma Pharmaceuticals

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Control Supervisor

  • Oct 2008 - Jul 2013

  1- Checking and giving approval for finished products.2- Dealing with methods of analysis, specification sheets and pharmacopeias monographs (USP, EP, and BP) especially USP.3- Working under cGmp's and GLp's and FDA regulations4- Prepare and Review the out of specifications, variances and verification of results reports.5- Excellent knowledge in FDA, and ICH requirements.6- Preparing and reviewing method of analysis, certificate of analysis and standard operating procedure (SOP) enter the QC department.7-Plan and distributed the daily routine work and day to day activities.8- Create/ update or developing method of testing Perform trend analysis9- Ensure implementation of CGMPs/ GLPs and safety compliance10- Release/ quarantine/ reject materials11- Review and check the instruments calibration data program12- Tracking for retesting13-Follow up the proper archiving of data / easy retrieval14- Follow up samples received from purchasing and reserve samples of raw materials.15- Evaluate and approve the new vendors for raw and packing materials and reduce testing programs.16- Check the availability of all required item needed for analysis.17- Generate process validation report18- Follow up on working standards availability and standardization/ retesting dates.19- Follow up the deficiency letter. Show less

• Quality Control Analyst

  • Oct 2004 - Oct 2008

  1- Assay, related substances and content uniformity for finished products in different forms (Ampoule, Cream, Tablet, Capsule, Vial, Suspension, Syrup, Powder and Suppository).2- Assay and related impurities testing for active pharmaceuticals ingredients.3- Standardization for several active pharmaceuticals ingredients according to the USP, EP and BP pharmacopeias.4- Dissolution testing and dissolution profile for finished, stability and R&D submission products.5- Cleaning verification samples Method validation procedure and testing using HPLC UPLC and UV spectroscopy.6- Process validation batches testing and approvals for these processes.7- Calibration and qualification for HPLC & UPLC instrument and troubleshooting at the needed time.8- Physical Testing Instruments: Conductivity meter, pH meter, Optical rotation, Loss on drying and Particulate matter.9- Infrared Absorption Instrument: Identification test (Qualitative test).10- Ultraviolet Absorption Instrument: 10.1Assay testing, dissolution, content uniformity and cleaning verification sample (Quantitative test).10.2 Identification tests comparing the maximum λ for sample and standard (Qualitative test). Show less