Head of Quality Assurance
Abdul Monem Bran Oil Company Ltd.
Total years of experience :14 years, 11 Months
Quality Management System (QMS)
• QMS is established, implemented, maintained, & audited for the process.
• Clear, concise policies, procedures, instructions, forms, objectives are provided & maintained.
• Preparation & update of Site Master File and Quality Manual.
• Develop, implement, manage & maintain QMS (ISO 9001, 22000).
• Conducting internal audits related to QMS, Lab- QMS. External audits (Vendor/supplier audit).
• Management review meetings, minutes & proceedings for circulation & follow-up actions.
• Change Control, Deviations, CAPA, Market Complaints, Annual Product Review.
• Use and adapt databases of programmatic data to make data-based program-management decisions
• Develop systems to manage customer defect/ feedback analysis, root cause analysis and corrective actions.
Quality Assurance
• Determining, negotiating and agreeing on in-house quality procedures, standards and specifications
• Specifying quality requirements of raw materials with suppliers
• Ensuring that manufacturing processes comply with standards at both national and international level
• Review and implement efficient quality and develop inspection systems.
• Facilitate proactive solutions by collecting and analyzing quality data and statistical report.
• Keep records of quality reports, statistical reviews and relevant documentation.
• Work as a liaison between executive team and department managers in communicating employee expectations in light of new corporate initiatives.
Validation & Verification
• To manage all operational validation activities within the organization.
• To continue to develop and implement an efficient compliant and cost effective calibration and maintenance programme.
• To work closely with all departments and the Quality Department to ensure the operation of a validated environment according to GMP and other regulatory requirements
• Be capable of delivering high level reporting to the reporting supervisor.
• Manage all facets of assigned validation projects while maintaining strong communication with representative on project status and assistance needed.
Preparation & update of Site Master File and Quality Manual.
Periodically documentation for compliance with internal/external Regulatory Policies and Guidelines (cGMP's, SOP's, GQP/G's etc.), product inspections and standardized work instructions. Represent the business at global validation forums.
Handling of Change Control, Deviations, OOS, CAPA, Market Complaints, Investigation Reports, Annual Product Review.
Preparation, review and update of SOPs and other QMS related documentation.
Manage, use and adapt databases of programmatic data to make data-based program-management decisions
Conduct analysis and prepare progress reports as per needs.
Develop, implement and maintain systems to assure the quality of products and efficiency
Develop systems to manage customer defect/ feedback analysis, root cause analysis and corrective actions.
Ensure that agreed product specifications are met in accordance with quality standard.
Review and implement efficient quality and develop inspection systems.
Provide technical guidance to solve quality related problem.
Facilitate proactive solutions by collecting and analyzing quality data and statistical report.
Keep records of quality reports, statistical reviews and relevant documentation.
Conduct internal audits and external audits (Vendor/supplier audit).
Prepare and evaluate performance reports with executives to help track progress towards company goals.
Work as a liaison between executive team and department managers in communicating employee expectations in light of new corporate initiatives.
Any other QMS related activities as & when required.
1. Ensure only approved materials are used in production.
2. Conducting all Physical, Analytical and Microbiological tests of RM, PM & FG.
3. Monitoring GMP compliance, plant cleanliness, pest control, environmental monitoring critical hygiene procedure, staff health, water quality and ensuring its effectiveness.
4. Monitoring In Process checks in Process and Packing activities.
5. Ensuring collection of reserve samples and their storage and management, testing market pickup sample.
6. Checking BMR, calculating & reporting daily nRFT, checking artwork.
7. Monitoring implementation of change control, CAPA, reviewing data, assessing problems and monitoring effectiveness.
8. Implementation of effectiveness dispatch of Finished goods from factory.
9. Participate in team to improve In process control and solving the issues and complaints.
10. Develop, implement & coordinate QMS requirements throughout the process integrated with HACCP. Participating on gap analysis, risk assessment & management and document upgrading activities.
11. Participate in team to conduct hygiene, 5S and safety audit in plant and premises; participate in self inspection of QA.
12. Participate in validation activities of process, packing and system.
13. Conducting calibration of all equipment listed in the calibration master list according to pre determined frequency.
14. Effective co-operation with production, engineering, warehouse, sales and HRD and product supply in order to solve quality issued.
15. Approval/ Rejection of RM, Pm & FG, Batch release and giving area line clearance in absence of Departmental In charge.
16. Take part in all related activities to implement Quality Management System in MFPL as guided by superiors.
1. Ensure Inspection of all working areas & equipments for cleanliness before starting manufactur-ing & packaging operations.
2. Perform all in-process inspections during manufacturing & packaging operations as indicated in BMR & BPR respectively.
3. Maintain record of all in-process checks & findings.
4. Report any deviation/ mistake observed during manufacturing process or packaging operation to reporting supervisor and provide necessary instruction for immediate correction.
5. Compile batch documents as per batch history check list for product release purpose.
6. Collect QA retention samples from every batch as per schedule & preserve those properly.
7. Inspect market returned products & other non-conforming materials and submit report as in-structed by the Reporting Supervisor.
8. Assist other QA personnel as directed by the immediate superior.
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