JMI Syringes and Medical Devices Ltd
Total des années d'expérience :14 years, 8 Mois
Employer: JMI Syringes and Medical Devices Ltd. (JSMDL)
(ISO-13485, CE 1015 Certified)
Quality Assurance Department (QAD)
Chaudagram, Comilla.
Period: 25 August 2012 to date 2014.
Period: 18 February 2009 to date.
Position: Manager, Production and Quality Control
Responsible for: The overall management and supervision of the
Plants Production Processes and Quality Assurance & Quality Management System.
Additional: FSMS Team Leader, Food Safety Manager, Compliance
Manager
Responsible to: Managing Director
Key Responsibilities Performed in Food Safety Management System (FSMS):
Expertise and Key Responsibilities Perform in Food Safety Management System (FSMS): -Specialized in Quality Control, Quality Assurance, Quality / Food Safety Management System --Documentation & Implementation, Well versed with ISO, HACCP, OHSAS, GMPs, GLPs, etc.
-InHouse Training of Company Employees about GMPs, GLPs, Hygiene & House Keeping, Awareness of Quality / Food Safety Management Systems.
-Internal Auditor of ISO-22000, Food Safety Management System (FSMS) . I have been serving as MR / Food Safety Team Leader in addition to other responsibilities.
-Professional Expertise: * HACCP and GMP Gap Analysis. * Quality/Food Safety Planning
-Quality/Food Safety Training * Integrated Pest Management * Food Safety Inspections of Plant * Documentation, Implementation & Auditing of ISO 9001, ISO-22000, GMPs & GLPs.
-Help in maintaining and upgrading the company;s Quality and Safety Management Systems.
-Handle and investigate the root cause of the customer complaints in order to minimize number of complaints.
-Prepare and arrange for ISO & ISO external & internal audits in order to meet the system requirements.
- Plan, schedule and perform GMP, Hygiene & Sanitation Audits of factory to assure that food products comply with the food safety requirements.
-Food Safety/Hygiene annual budgeting, objectives/target setting and their achievement planning.
-Prepare Hygiene Plans and follow up the implementation through Hygiene Audits to meet Food Safety requirements.
- Plan, Design and conduct training of company employees as per Training Needs Assessment / Training Plan.
- Monitoring of Integrated Pest Management activities in the factory and liaison with pest control service providing company to eliminate any gap.
-Liaison with the certification body for Quality/Food Safety Management System audits.
-Communicate with all other departments regarding issues in the Quality & Food Safety Management Systems.
- Executed training programs for company employees in order to give awareness about ISO, GMPs, Hygiene/Sanitation and Food Safety.
-Conducted Hygiene & Food Safety audits of company warehouses. Ensure that QC functions of incoming, inprocess and final inspections are carried out promptly as per the given BSTI standard specifications.
-Develop and maintain raw/packaging material and process control norms and their effective implementation.
-Ensure implementation of Quality, Environmental & Health/Safety standards laid down in ISO, ISO & OHSAS
-Plan, schedule and execute internal audits to ensure compliance to ISO, & OHSAS.
-Liaison with local and regulatory bodies and full compliance of specific requirements with respect to product quality, safety, health and environment.
-Reporting to top management on the performance of Quality, Environmental & Safety Management Systems and any need for improvement. Ensure that in process and finial products are inspected as per documented procedures.
- Ensure that Quality Control staff is performing their duties as per the job description. * Ensure that food safety inspections are carried out as per documented procedures.
- Monitoring GMP, Hygiene and Sanitation conditions of factory and report to Management.
- Ensure the implementation of pest control practices in the factory as per pest control plan.
-Coordination with the Product Development Department regarding ongoing new developments in products and packaging. Achievements: -Certification of organization for ISO: working as MR.
-Ensure that incoming raw and packaging materials are according to the pre determined standards.
-Ensure that inprocess and finial products are inspected as per documented procedures.
-Monitoring hygiene and sanitation conditions of plant and factory to comply with the HACCP requirements.
- Ensure the implementation of GLPs in the physical/chemical and microbiological labs.
- Development of ISO and HACCP procedures and their implementation in the company.
-Handling customer complaints, their investigation & corrective/ preventive action. Achievements: - Making production schedule by considering the market demand and warehouse stock.
- Ensure that lines are giving daily output at maximum efficiency and targets being met.
- Utilization of man power effectively to get maximum output from the available resources.
-Making production report and update management regarding performance of plant. Trainings/Workshops:
-Lead NABISCO Food Safety Management Team (FSMS) as a Team Leader to overall development of factory to implement Food Safety Management System
- Lead NABISCO to the DPE (Directorate of Primary Education) efforts to strengthen the DPE-EU School Feeding Program.
-Leading NABISCO FSMS Team to the compliance of Food Safety Management Prerequisite Standards of World Food Program (WFP)
-Providing leadership as required in setting up a supply chain with commodity handling and management and appropriate quality control measures for the timely distribution of Fortified High Energy Biscuits to the DPE-EU school Feeding Programme.
-Provide guidance on selection of vendors for supply of raw materials for the fortified high energy biscuits.
-Supervise and monitor directly the quality control issues including manufacturing processes to be followed.
-Liaise with Project of DPE-EU School Feeding Program, WFP and also FSMS Certification auditors SGS to undertake any activities as a prerequisites.
-Assist the Quality Control Agency of DPE School Feeding Program to implement any prerequisite program necessary for implementation of the Food Safety Management System and strengthen the school feeding program of DPE.
-Communicate regularly with DPE Project Office and EU Quality Control Agency also with WFP and BSTI as authorized contact person to share information on any program, logistics and achievement of project objectives.-
Manufacturing/Production
1 Oversee the production/manufacturing of 15MT/Shift (8h) Cookies & confectionaries on daily basis.
2 Prepares the production schedules for the facility's different production lines to ensure proper and full utilization of machines & manpower (almost 960) i.e.; schedule for each of production line-1 to line-4 as per demands routinely.
4 supervise the implementation of all standard working & food safety procedures in the department. Oversee the overall cleanliness and higienity of the production area and the factory floor as per GMP in particular.
5 Oversee the technical performance of each oven from line-1 to line-4 to ensure production rate on daily basis.
6 Co-ordinates with the sales Dept. to facilitate production and operations based on the market demand.
7 Participate with the Director Operations in setting a production strategy that complies with the market trend.
8 Review and approve production analysis reports on finished products, and semi-finished, including investigations of any errors in the production process. implements manpower plans (i.e. shifts) to maximize employees efficiency.
9 Participates in performance evaluation of the workers, prior to bonus distribution, salary increments, and promotions, if any.
11 Periodically updates and report the status and production performance of each production line.
Training and Orientation
Prepares yearly training programme for all staffs concerned in manufacturing process, quality control, packing supervision, health, hygiene and cleanliness etc.Evaluates performance of the officers and staffs for skill development and recommends training also conducts orientation for new officers recruited in the factory.
Management and Recruitment
Actively participates in all the recruitment process of NABISCO.Member of the recruitment committee and interviews, reviews any new jobs recruitment in the factory also manages the factory production staffs activities on daily basis
Product Development
Prepares pilot batches for new formulated products.
Conducts shelf life stability studies of new and revised (if any) products as per BSTI standard specifications.
Specification Development
Develops specification for products and raw materials for quality analysis according to BSTI standards.
Quality Control
Supervises the analysis of raw materials and finished products as per BSTI Standards according to the quality control scheme of inspection.
Maintenance Department (Electrical & Mechanical)
Approves and ensures the supply of spares necessary for maintenance of machineries like printing, packing, sealing, geard motor, oven cooling tower etc.assessed & demand by the foreman. Approves and ensures the supply of spares necessary for electric installations including generators, oven, cooling tower etc.assessed by the foreman.
.
Co-ordination with other Stakeholders
Co-ordinates with different stakeholders like WFP, ACF, NIPSOM, BSTI, ILO, Engineering Company's etc.to maintain the interest and growth of company sales
Planning
Plans any future development with MD, Director and other relevant management officials for the future sale growth of the company.
Employer: Bangladesh Arsenic Mitigation Water Supply Project.
(A WORLD BANK Project)
Period: 18July2002 to 30June2006
Position held: Laboratory Coordinator, (Head, DPHE Zonal laboratory, Barisal)
Description of Duties: • Implemented GLP AND SOPs as per ISO-17025 and ISO-14001 procedures and instructions for DPHE central laboratory, Mohakhali, Dhaka and zonal laboratory, Barisal.
• Developed and Validated Standard Operating Procedures (SOP) for estimation of Arsenic (As), Iron (Fe) & Aluminium (Al) by Atomic Absorption Spectrophotometer (AAS)
• Supervised and Monitored QA/QC of the Laboratory Based Analytical Activities
• Supervised QC/QA of the Programme Activities
• Analysis of Ground Water of Pourasavas Production Wells (PWs) i.e.;Deep Tube Wells
• Programme Co-ordination & Supervision (Managerial & Technical)
• Prepared and presented reports by power points.
• Supervised Proper Wastes Management (ARTs)
• Performed Proper Operation, Maintenance and Troubleshooting of AAS
• Proper Training on Safety, Health & Environment (SHE) for Laboratory Personnel
Employer (Current): NABISCO Biscuit and Bread Factory Pvt.Limited (NBBFL) (ISO22000 & EU Compliant Company)
Employer: ACI Pharmaceuticals (Advanced Chemical Industries Ltd.) (ISO9001, ISO14001 Certified)
Product Development Department
Narayangonj Industrial Park, Narayangonj
Period: 07June1995 to 15June2000
Position held: Product Development Officer
Description of Duties:: ( Responsibilities Performed)
• Ensured smooth operation of all activities of the quality assurance and product development department.
• Performed formulation development & review, stability study as per regulatory requirements.
• Ensured compliance of manufacturing process validation as per GMP procedures and instructions of new pharmaceutical products under development.
• Ensured compliance of all quality assurance parameters for new pharmaceutical products under development as per specifications.
• Developed and validated analytical methods for new pharmaceutical products under development.
• Developed and maintained individual pharmaceutical products master file.
Introduction of ISO 9001
• Conducted implementation pertinent procedures and instructions of the quality management system ISO 9001 to ensure compliance to quality policy of the organization
QA/QC of Pharmaceutical Products: • Performed all physical & chemical (QA/QC) tests as per USP for new pharmaceutical products under development
• Manufactured several trial batches as per cGMP of new pharmaceutical products with different suggestive formulations
Developed & Validated Manufacturing Process of New Pharmaceutical Formulation for following Products: Developed and Validated of Analytical Assay Methods
Validated Analytical Assay Methods
Linearity and Range
Sensitivity
Specificity, Precision/Ruggedness
Accuracy/Recovery
Developed Manufacturing Process validation Protocol
Shelf life Study of Pharmaceutical Product
Instrumentation Expertise: Estimated Heavy Metals like Arsenic, Lead, Iron from Drinking Water by: Atomic absorption spectrophotometer Shimadzu Model AA 6800 (flame based) Japan, Atomic absorption spectrophotometer Shimadzu Model AA 6300 (hydride vapor generator) Japan, Varian AA-220 Atomic absorption spectrophotometer (AAS)
Estimated Active Ingredient From Pharmaceutical Products Formulation By: High Performance Liquid Chromatography (HPLC) Waters, FT-IR, Potentionmetric titre,
Used E-pure deionization water unit, ultra pure distillation unit for demineralized water (Analytical Grade Water)
Bacterial Count By: Portable microbiological instruments,
Estimated Iron, Manganese etc. By: UV-Visible spectrophotometer (DR 4000),
Estimated Retinol/Vitamin-A From Human Plasma/Serum By: High Performance Liquid Chromatography (HPLC),
Estimated Moisture from Pharmaceutical Products By: Karl fisher Machine,
Others By:Centrifuge machine, pHmeter, Incubator, Turbid meter, COD reactor, vortex mixer, Conductivity/salinity/TDS meter, Filtration unit, Turbidimeter, dehumidifier
Position held: Manager Quality Assurance (Head of Quality)
Direct Reporting: Head of Group Quality
Indirect / next level Reporting: Managing Director / Chairman
Description of Duties:: ( Responsibilities and Activities)
1. Be responsible for final approval for releasing of Finished Products.
2. Overall management of Quality Control and Compliance functions (including Microbiology) as per ISO 13485 guidelines.
3. Be responsible for new product development and current problematic marketing complaint product.
4. Final judgement of purchased materials and components whether or not these are to be released in case they are nonconforming.
5. Review Quality Manual and approval of routine procedures, operational procedures of the site & also ensure GLP in QAD lab.
6. Ensure various meetings such as Co-ordination meeting, Monthly Quality Meeting etc on a timely manner.
7. Control & manage routine jobs in accordance with the administrative system of the site for Quality Assurance Department.
8. Responsible for review & final approval of packaging design.
9. Implement an effective change control process if any change is initiated by any department.
10. Ensure no product is released without issuing of certificate of analysis (COA)
11. Control and manage all the routine jobs in accordance with the planned arrangement of Quality Assurance Department.
12. Conduct company-wide GMP & ISO training of all personnel to enhance their knowledge.
13. Analyse all customer complaints and take necessary corrective & preventive actions (CAPA) for rectification.
14. Review of suppliers & handling of supplier audit as per ISO 13485 guidelines.
15. Handling, evaluation and overall management of Quality objectives & records as per ISO 13485 guidelines.
16. To guide and monitor to ensure implementation of cGMP in every aspects of routine operation and ensure fulfilment of regulatory requirements.
17. Co-ordination between all departments to take CAPA if violations are observed in the internal audit as well as external audit (public authority, notified body and customers)
18. Conduction and handling of serious complaint and nonconforming meetings.
19. Handling of Risk Management.
20. To plan and coordinate for preparing, reviewing and regular updating of SOPs, Quality Manual, Technical File (TF) for CE marking, approved vendor list, manufacturing processes, specifications & methods of analysis and other relevant document.
21. Ensure calibration of all equipments on time through liaison with BSTI.
22. Implement In-process control (IPC) inspection related activities during production through forming an effective in-process team.
23. Ensure validation, revalidation and/or routine monitoring of EtO sterilization.
24. Ensure control and validation of the manufacturing environments (clean room)
25. Control of risk analysis and risk management.
26. Control of non-conforming materials, products and their reports.
27. Perform / Implement any other QA/QC activities/responsibilities not mentioned above when necessary assigned by Head of Group Quality or as given by top Management.
• Master of Public Health (MPH) with Major in Environmental Health in March 2010 from School of Environmental Science & Management, Independent University, Bangladesh (IUB), Baridhara, Dhaka. Website: www.iub.edu.bd/chpd/index.htm
• Master of Science in Chemistry, with Major (Thesis) in Chemistry from Dept. of Chemistry, Jahangirnagar University, Savar, Dhaka in 1995. Website: www.juniv.edu
• Higher Secondary Certificate Examination from Notre Dame College, Dhaka, in 1983.
• Bachelor of Science (Honours) with Major in Chemistry from Dept. of Chemistry, Jahangirnagar University, savar, Dhaka in 1991Website: www.juniv.edu