Acting as Quality Control Manager
Dammam Pharma
Total years of experience :19 years, 4 Months
Leading and manage the quality control department activities
My responsibilities there were as follows:
1.Leading the raw materials & packaging materials team members.
2.Supervising all tasks of raw materials & packaging materials team by distribution of daily work tasks, follow-up completion of tasks and evaluate the whole analysis processes.
3.Follow-up daily production plans and various production lines to address the highest-priority market needs first in analysis.
4.Providing technical support and trouble shooting for the raw materials team and any other colleagues on QC lab instrumental problems such as HPLC, GC, Atomic Absorption, Viscometer, NIR & Malvern Mastersizer.
5.Responsible for the approved supplier system implementation and follow up.
6.Ensure that employees follow SOPs of analysis, GMPs, GLPs and GDPs.
7.Issuing the certificate of analysis and any other document relevant to my responsibility.
8.Preparing Investigation reports when required using the appropriate predetermined forms.
9.Reporting deviations, suspect results, out of specification results and any other required reports.
My responsibilities there were as follows:
1.Leading the QA compliance team members.
2.Ensure appropriate implementation and maintenance of GMP/GLP Quality Systems in compliance with both regulatory and company requirements.
3.Perform continuous internal auditing on the manufacturing area & warehouse to assure compliance with cGMPs, cGDPs and cGSPs.
4.Coordinate the audits received from Jordan, Bayer, J&J, or from anywhere.
5.Review of Batch Manufacturing Records and Master Formula.
6.Owner of the approved supplier system implementation and follow up.
7.Review and/or update standard operating procedures relevant to the quality system.
8.Review raw data generated for submission as well as those for batches exported to regulated market.
9.Responsible for the planning & implementation of the training system within the quality department.
10.Responsible for compliance of all dedicated activities to the recent updated guidelines.
11.Responsible for dealing with equipment agents and vendors to call for maintenance or to purchasing new equipment.
12.Review Equipment's qualification, calibration and preventive maintenance.
13.Review validation master plan according to the predetermined procedures, references and guidelines.
14.Monitoring and periodic evaluation of the effectiveness of the quality policy by reviewing the technical documents like (SOP’s, specifications, protocols, change controls, deviation).
15.Coordinate with regulatory Affairs in preparing all submission files.
16.Assure that proper training has been performed for employees on the relevant SOPs.
17.Responsible for issuing, updating and control the laboratory work sheets.
18.Review and/or update methods of analysis and specification sheets to assure regulatory compliance.
19.Follow up the document control process & Revision of all documents (Manuals, Procedures, Forms, Instructions and Training Manuals, etc ....).
20.Review and confirm raw materials certificate of analysis sent by the purchase department of pre-shipment and new supplier for raw materials.
21.Responding the quality assurance and R&D departments for the issues related to the raw materials specifications.
22.Responding the regulatory affairs and registration department for issues related to Ministry of health validation and comparative in-vitro studies conducted by our team.
23.Review all raw materials specifications and methods of analysis.
24.Participate in investigation teams to resolve any issues that may appear related to the quality of the product.
25.Handling of deviation, change control, Complains, Recall & CAPA systems.
26.Follow up the status of the logbooks forms issuing, laboratory requirements in the logbooks and printing with purchasing department and print house.
27.Conduct training sessions whenever needed and/or applicable.
28.Follow up the proper archiving of data and files.
29.Assure that personnel involved in GMP/GLP tasks are trained and qualified.
My responsibilities there were as follows:
1.Leading and supervise the finished product team.
2.Supervising all tasks of finished product & Stability team by distribution of daily work tasks, follow-up completion of tasks and evaluate the whole analysis processes.
3.Follow-up daily production plans and various production lines to address the highest-priority market needs first in analysis.
4.Distribution of daily tasks for stability team, follow-up and supervising the completion of tasks and evaluate the whole analysis processes.
5.Determine the required samples of the required lots and follow up the sampling procedure with the QC technician.
6.Providing technical support and trouble shooting for the finished team and any other colleagues for instrumental problems.
7.Responsible for ensuring that all the necessary sampling, testing and calibration are carried out as per the approved specifications and SOP’s.
8.Maintain out of specification log books, inspect, investigate, and take samples, in order to monitor factors which may affect product quality.
9.Issuing certificate of analysis and validation reports for any production batches when required.
10.Reporting change controls when required using the appropriate predetermined forms.
11.Preparing Investigation reports when required using the appropriate predetermined forms.
12.Reporting deviations, suspect results, out of specification results and any other required reports.
13.Documentation of analytical results according to the predetermined procedures and reporting events according to the applicable procedures after having the necessary training on the process.
14.Reporting any other event or observation concerning equipment, utility, method, product or procedure and any other relevant item in the quality control department.
15.Review and check the daily raw data generated under my supervision.
16.Support registration of new and existing products by providing technical documents required by different regulatory bodies.
17.Responsible for sample pulling on the due date and testing the samples according to the applicable approved analytical procedure.
18.Ensure that the latest test method and specification are available.
19.Ensure that employees follow SOPs of analysis, GMPs, GLPs and also GDPs.
20.Check the availability of all required items needed for analysis (Columns, reagent…).
21.Perform proper training for employees.
22.Check and signing off on COA.
23.Results recording on SAP system.
24.Ensure cGMP and safety compliance.
25.Review and check the calibrations data.
26.Follow up the proper archiving of data.
My responsibilities there were as follows:
1. Supervise the raw materials & packaging materials team.
2. Full analysis of incoming raw materials according to British Pharmacopoeia, U.S. Pharmacopoeia Standard methods and internal specifications.
3. Report any problems or deviations in packaging procedures on an immediate basis to ensure that incorrect packaging does not take place.
4. Report any problems or deviations in packaging procedures on an immediate basis to ensure that incorrect packaging does not take place.
5. Plan and distribute the daily routine work and day to day activities.
6. Review and check the daily raw data generated under my supervision.
7. Notify QC manager about any OOS results obtained in the routine analysis testing in order to perform proper investigation and follow up.
8. Follow up samples received from purchasing and reserve samples of raw materials.
9. Review and check sampling.
10. Perform proper training for employees.
11. Member in the internal audit team.
12. Member in the internal audit team.
13. Ensure cGMPs and safety compliance.
14. Carry out performance evaluation.
15. Follow up on analytical trouble shooting.
16. Ensure that employees follow SOPs of analysis, GMPs, GLPs and GDPs.
17. A member at team preparing chemistry and instrumental Laboratories for ISO 17025 accreditation.
18. Update or create standard operating procedures, specifications sheets and method of testing.
19. Check the availability of all required item needed for analysis (Columns, reagent…).
My responsibilities there were as follows:
1. Full analysis of incoming raw materials according to British Pharmacopoeia, U.S. Pharmacopoeia Standard methods and internal specifications.
2. Examine pharmaceutical packaging machinery at the beginning of each shift to ensure good working order.
3. Report any problems or deviations in packaging procedures on an immediate basis to ensure that incorrect packaging does not take place.
4. Preparation of chemical reagents and other required volumetric solution as directed.
5. Implement standard operating procedures.
6. Working on various instruments as HPLC, Near-IR, Malvern, UV-VIS spectrophotometer, Dissolution tester, GC and TOC.
7. Prepare associated packaging documentation according to provided SOPs.
8. Follow the cGMPs, cGLPs and safety precautions.
9. Perform calibration and calibration checks as needed.
10. Follow the documentation system requirements.
11. Follow and preparing reagent solutions and other analytical requirements.
12. All required activities to ensure quality and quantity of work and cost effectiveness with compliance of cGMPs, cGLPs and safety requirements.
I have such a reasonable experience in the quality management field gained from my more than 9 years working experience in the quality control, quality assurance and compliance field at Delta pharma & Hikma pharmaceutical Egypt manufacturing plants, I believe this knowledge is applicable in every field covered by a quality system ( not limited to pharmaceutical industry, but goes further to other industries & services and any other field of work) Iam looking forward to apply my knowledge and skills in major organizational changes towards quality and excellence culture, i have unique plans and tactics to achieve this goal in a professional manner which will further be reflected in the business outcome of any organization i am working with
