Experience

Dammam Pharma

• Saudi Arabia
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Services Manager

  • Mar 2016 - Present



SPIMACO

• Saudi Arabia
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Compliance Manager

  • Jan 2008 - Present

  - Ensure that all operations related to products and services are in compliance with current regulatory expectations and cGMP's as stipulated in US FDA 21CFR, MHRA, EMEA, EU, PIC/s, Licensor's GMP , local Regulatory (SFDA) requirements and company QMS -Management and improvement of programs, compliance with regulatory requirements ,expectations , company policies and practices.- Design and implements programs, policies to ensure that all business units are in compliance with Local and International regulatory requirements.-Manages changes in systems, procedures, facility, equipment, and etc when necessary to improve quality and compliance.-Review all cGMP related documentations ( e.g. SOPs WIs, MPS etc) for Quality, Environment, Health, Safety, systems, equipments & manufacturing processes, including quality & technical agreements, facility design & layout, reports, validation & qualification policies, procedures, plans, protocols, and reports for the final approval .-Facilitate and Manage all external audits (Regulatory & Licensor's) and make follow-up of audit observations and corrective and preventive actions (CAPA) till satisfactory closing of the audit .-Perform the GMP Audits of different organizations / company's, raw and packaging materials suppliers, Distributor Warehouses .-Conduct processes & meetings of management review and GMP & Quality System Committee in timely and effective manner and update the senior management on the current status of cGMP & Regulatory Compliance along with recommendations.-Provides technical expertise and support during investigation, design, review, validation & qualification, risk assessments, change control, audits and etc. to all concerned.-Regularly update & improve the company System in compliance with current regulatory expectations, Licensor's and cGMP requirements by eliminating the GAPs identified by conducting self GMP Assessments visits and GAP Analysis. Show less

• QA Senior Supervisor ,Environmental & Hygiene Section

  • Jun 2000 - Dec 2007

  -Ensure that all aspects of the environment are contaminant free for pharma production.-Ensure the effective monitoring and control on in-plant sanitation and hygiene to cGMP Standards.-Qualify the production area as per the relevant GMP and Environmental standard.-Ensure that the environmental routine schedules and standards are established, monitored , revised to ensure the conformance to the approved procedures and GMP regulations-Monitor the status of the Viable and non-viable count of the production facility to ensure cleanliness of the areas .-Ensure the effectiveness and integrity of the HVAC filtration system through monitoring and trending of the data.-Ensure the effectiveness of the water system through monitoring and trending of the data.-Ensure the effectiveness and integrity of the Compressed gases system through monitoring and trending of the data.-Ensure the effectivness of the storage conditions of the warehouse and cold rooms storage areas through Qualifications, monitoring and data trending as per the GSP and GDP-Conduct GMP induction /Refresher Training for all new employees /current employees on GMP Sanitation&Hygiene and Environmental Qualification/Monitoring.-Conduct/review of the risk assessments for all operations to ensure effective contamination control and prepare/follow up the mitigation plan. -Ensure the control of waste as per waste management procedure and legal requirements.-Qualification and monitoring of the equipments used in production and QC laboratory.-Ensure that plant air emission are within the legal requirements through monitoring of the ambient air and waste water.-Ensure the effective implementation of the HSE (Health, Safety and Environment) system as per the ISO 14001 and OHSAS 18001 requirements. Show less