Total Quality Manager
Kasih Food Production Company
Total years of experience :28 years, 4 Months
Duties:
•Build up and construct comprehensive quality management systems from scratch and this includes all functions in the organization: Technical (QA, QC, production, TQM), administrative, sales, marketing, and financial
•Certification of the company for BRCGS, HACCP, ISO 9001, vegan, Non-GMO, gluten-free, and Halal certificates
•Set the basic strategic processes that handle SWOT analysis, creation of strategic plans, and direction for the organization
•Improve the vision, mission, and quality systems that enhance customer satisfaction and competitive advantage of the organization
•Oversaw a wide variety of quality operations across all departments in the company
•Set a total quality management system that supports compliance to cGMP and quality certificates for the organization
•Evaluation and acceptance of the new potential suppliers for the organization through quality audit and document review
•Manage the change control, deviation control, and NC products (market complaints, product recall, OOS)
•Manage the deployment of food safety culture and policy to ensure the SISPQA (Safety, identity, strength, purity, quality, and authenticity) for the products
•Manage the creation and development of product design, recipe, ingredients, technical specification, packaging configuration, batch coding as per the approved regulatory standards (JFDA, SFDA, US-FDA, GCC, European Celex), and customer needs
•Manage the product registration locally (JFDA), and globally (SFDA, GCC, Europe, US-FDA, and Canada)
•Create and manage simple and agile archiving systems for the daily records that are generated upon implementation of various business processes in the organization
•Participation scientifically in the food product research and development and support to design experiments as per the fractional factorial design
•Manage the integrated pest management, calibration, and external testing with global laboratories
•Manage the environmental programs and validation studies in the organization (Product, process, hygiene control, allergen control, utility control, foreign bodies detectors, temperature distribution, heat penetration studies for acidified food and low acid food products - ACF and LACF)
•Manage the food safety and HACCP team to manage and improve food safety and food defence systems
•Manage the internal quality audit in the organization to ensure compliance and adequacy of TQM systems
•Manage continual improvement of the organization to match strategic goals and quality policy
•Coordinate organizational performance in order to improve the application of TQM tool
•Coordinate management review process in order to maintain PDCA cycle and CAPA implementation
•Manage training system that enriches the awareness of staff to soft and job skills
•Participate in new product development (NPD) including product ideation, troubleshooting, product development and prototype, design development, testing method development, stability study, and registration
•Participate as a member in corporate risk committee to handle the potential risks either in the dynamic external environment or internal corporate environment with a role in the execution of mitigation systems
•Participate as a member in corporate strategy committee including the annual meeting with the board of directors, setting strategy plans, issuing of business processes that have impact on strategy for the purpose of strategy implementation, handling strategy KPIs, and continual improvement Achievements:
•Certification of the organization for BRCGS certificate within one year to enhance engagement with global B2B customers
•Attainment of grade A then AA for two consecutive years upon annual BRCGS certification
•Certification of the company for Non-GMO, vegan, Halal, and gluten free which enable to penetrate new markets.
•Preparation of total quality management system to be compatible and ready for digital transformation
•Creation of agile and simple system to archive more than 10, 000 reports efficiently using the current resources and retrieval of any report will be in seconds and ability to complete traceability and mass balance within a maximum of two hours
•Lead to pass the external quality audit satisfactorily such as AIB, USFDA, JFDA, and global customers such as Del Monte
Duties:
•Managed QA, QC (including microbiology lab), and validation departments
•Ensured implementation of quality and safety policy
•Defined the strategic and business objectives of total quality department in terms of KPIs
•Acted as Quality responsible person to manage PQS, material compliance/release, product compliance/releases prior to shipping to market, cGMP compliance certificates, quality risk management, (QRM) and contract manufacturing
•Ensured that the PQS is followed as per contract manufacturing throughout the contract life cycle
•Ensured the correct set up of PQS and business processes (Production/manufacturing, sales/marketing, finance/accounting, human resources) to match requirements of new product launches, new business opportunities, internal QA policies, and cGMP/regulatory requirements
•Ensured regulatory, high quality standards, and cGMP of the products according to the specific requirements at different markets and contract manufacturing that conducted in the site
•Led and participated in annual quality management review meetings that evaluate the major outputs of the organizations in terms of PQS, quality compliance, and quality risk mitigation measures
•Ensured an effective root cause analysis (RCA) in case of discrepancies of products (out of specifications, product deviation, customer complaints )and PQS (as a output of self quality audit and third party audit) to establish a cohesive corrective and preventive action plans (CAPA)
•Maintained the effectiveness / implementation of product recall system according to cGMP standards especially conduction of mock withdrawal to verify capability of the ERP system to recover product batches distribution
•Managed the follow up of CAPA plans with respect to timely closing, and verify / validate the consequent applied PQS changes
•Managed change control system including the identity of change, rational for the change, impact assessment of change on product/PQS, documentation activities, validation of change (if any), follow up for timely closing according to the approved procedure
•Managed customer complaints related to products (quality and pharmacovigilance related) including investigation (RCA), setting CAPA, official reply to customers, follow up of timely and successful closing of CAPA
•Ensured the implementation of product quality review (PQR) system to strengthen continual improvement of materials and products specifications development
•Managed reporting system to summarize the output of PQS and give capability for assessment of quality issues and helping for fast quality decision making that maintain SISPQ (Strength, identity, safety, purity, and quality) of products
•Defined training needs of the employees in the site for the purpose of improvement of task performance, new technology transfer, new PQS procedures, and cGMP / regulatory compliance
•Managed validation master plan and validation tasks (IQ, OQ and PQ) for production equipment, utilities, plant, laboratory instruments, and cleaning programmes
•Managed the suppliers of materials with respect to quality, audit, evaluation and qualification
•Managed the control of site master file and active documents that has impact on product quality
•Oversaw wide variety of quality operations and activities of 80 employees across QA, QC and validation departments
•Followed up quality objectives and performance metrics that support strategic directions of organization
•Coordinated organizational performance excellence in order to improve productivity and compliance
•Set the time standards that advanced efficiency in terms of cost and commitment to customers
•Led and continually improved quality control laboratory with respect to high technology and validation
•Achievements:
•cGMP certification in line with Health products Regulatory Authority, HPRA
•Certification of the company for cGMP at GCC authorities and SFDA
•Amplified the compliance rate of finished products as much as 99.5%
•Created a comprehensive GLP system that bonus QC performance by 25%
•Accomplished on-time orders by shortening the product release cycle
•Creation of software to recap QC data trending (OOS&OOT) for faster quality decisions
Duties:
•Designed and implemented from the ground up, division-wide structured QA/QC processes, which touched every aspect of organization
•Planned, organized, directed, and led quality department activities
•Acted as management representative in front of regulatory agencies
•Ensured implementation of quality management systems (QMS) as per cGMP, HACCP, ISO 22000 and ISO 9001 standards
•Managed, reviewed and approved Quality Manual (QM), Site Master File(SMF) and HACCP- food safety manual
•Led vendor evaluation to ensure compliance to internal policies, cGMP guidelines and manage updated list
•Managed internal quality audit to verify compliance of QMS to QA policies and international standards
•Led and assist with regulatory or customer or third party quality audit
•Ensured proper documentation management, development, distribution and control
•Ensured continuously providing of sanitization procedures and implementation of integrated pest management
•Managed, evaluated and recommended areas of improvement upon quality management review
•Managed, improved, and approved reports related to product quality review (PQR)
•Ensured customer satisfaction through proper handling and official reply to market complaints
•Improved and enhanced continual improvement of both QMS and resources
•Managed the change control system with respect to impact assessment and risk management
•Managed the deviation control system with respect to actual route causes, risk management and setting CAPA
•Managed validation master plan and validation tasks (IQ, OQ and PQ) for production equipment, laboratory instruments, process validation and cleaning validation
•Managed all technical matters related to QC laboratory
•Managed change control, deviation control, process variation and OOS systems
•Managed long term stability programs via creation of conceptual software for handling the OOT for the purpose of product quality review
•Managed the implementation of training and auditing program according to the approved system
•Managed control of printed packaging material design according to approved procedure, records and documents
•Managed specifications, testing methods and release of raw and packaging material
•Managed release of in-process materials and accordingly finished product for distribution and shipping
•Ensured continual improvement and safety matters in process and operation in QC and R&D labs
•Monitored and control manufacturing environment, utilities, plant hygiene and process validation
•Achievements:
•Construction of effective QMS from scratch which guided to certification for cGMP compliance
•Established high tech QC laboratory with optimum capacity to avoid unwanted extra QC testing costs (200, 000 US$ per annum)
•Facilitated new markets penetration by certification of QMS for ISO 9001, Halal, and ISO 22000; hence maximized total organization profits by 25%
•Tremendous decrease in customer complaints to be less than 2%
•Created effective QMS tools which enhanced product conformance rate up to 99.5%; hence diminished the cost of scrap by 25%
Duties:
•Conducted technical and feasibility studies for establishment of new pharmaceutical firms with respect to the industry requirements, cGMP standards, safety and environmental awareness
•Reviewed and evaluated the layout of premises, utilities and equipment to fulfil the cGMP requirements
•Developed the production lines or systems within the well established firms to improve operational efficiency and compliance of the pharmaceutical firms included in the group or new projects
•Achievements:
•Partnership with pioneer pharmaceutical companies such as E-Pharma in Morocco, hence maximized profitability
Duties:
•Played a key role in a project to register the pharmaceutical products under US-FDA requirements
•Participated in developing continuous organizational review board and processes
•Arranged for quality management review (QMR) meetings with top management and follow up satisfactory implementation
•Ensured management of SOPs related to PQS; acted as SOPs subcommittee Team Leader
•Managed, improved, and approved reports related to product quality review (PQR)
•Ensured customer satisfaction through proper handling and official reply to market complaints
•Managed the change control system with respect to impact assessment and risk management
•Managed the deviation control system with respect to actual route causes, risk management and setting CAPA
•Prepared, controlled and updated Site Master File and Quality Manual
•Managed, improved and evaluated the effectiveness of product recall system
•Conducted Internal Quality Audits of all departments to ensure effectiveness of PQS
•Performed audit for vendors of materials and services to ensure compliance to cGMP and company policies
•Led and assist with regulatory or customer or third party quality audit
•Managed, investigated and set remedies for the cases of OOS cases reported by QC
•Managed batch record, approve final release and managed all certification prior to finished product release
•Managed specifications and method of analysis of materials and products to verify cGMP compliance
•Set effective sampling plans and techniques for materials, products and QA/QC functions
•Managed all QA-IPC activities to ensure quality and compliance to the company and international standards
•Ensured execution of training of staff on quality systems and procedures according to training needs.
•Managed, reviewed and signed off the art work respect to product label and ingredients declaration
•Managed & followed up the executions of the validation, calibration and preventive maintenance schedule
•Evaluated and approved process validation protocols and reports
•Evaluated and developed production lines, lay out of premises and utilities to fulfill the cGMP standards
•Validated method of analysis for raw materials, in-process materials, finished products and cleaning verification
•Acted as team leader for business development and new markets task force that aim to enforce investment and alliances
•Acted as team member in the committee responsible for Abbreviated New Drug Application (ANDA) project
•Acted as a member in training subcommittee which improved efficient training systems
•Achievements:
•Established QMS system from scratch as per cGMP; hence enhanced quality performance up to 99%
•Created innovative business processes which enforced integration of quality activities; hence penetrated into European Markets and maintained competitive advantage of organization
Duties:
•Analyzed raw materials, packaging materials, in-process materials and finished products
•Responsible for in-process control and self-quality audit of production lines to verify cGMP compliance
•Validated method of analysis of raw materials, in-process materials and finished products
•Prepared and reviewed Standard Operating Procedures related to QC activities
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