أيمن إبراهيم

•Review and evaluate all data generated issues by different operations and quality control department and accordingly release or reject the raw, packaging and bulk materials or other objects under evaluation by the QC lab.
•Plan, coordinate and direct quality control program, design to ensure continuous production of products consistent with established standards.
•Develop and analyze statistical data and product specifications to determine present standards and establish proposed quality and reliability expectancy of finished products & raw material.
• maintains finished products & stability laboratory operational goals metrics for effectiveness and efficiency, as well as maintains and reports current compliance metrics and trend charts.
•Formulate and maintain quality control objectives to maximize product reliability and minimize costs.
•Direct, through intermediate personnel, workers engaged in inspection and testing activities to ensure continuous control over materials and products.
•Provide feedback and evaluations as needed and required for concerned departments.
•Troubleshoot laboratory instrumentation issues.
•Assist management of critical laboratory programs such as internal quality control program, measurement of uncertainty and analysis of all results.
•Provide technical expertise in support of the development of Q.C. testing methods & material specifications.
•Review validation of test methods validated by QC members after receiving from R&D.
•Ensure that qualified, skilled, and trained personnel and other resources are available.
•Assess the performance of QC Staff; recommend further training and practice to enhance their competency.
•Monitor training plan and matrix as required ensuring compliance and staff proficiency.
•Conduct all administrative duties including regulation of work hours, work shifts, overtime, etc.
•Act as a deputy for Quality Director to release the raw materials & packaging materials and finished products.
•Perform periodical employee appraisal for subordinates.
•Manage QC financial and budget aspects.
•Ensure the implementation of HSE regulation.
• To define with the agreement of the Vice chairman, the organizational structure and staffing of the Quality Control Group.
• To delegate responsibilities to those reporting as necessary and appropriately.
• To ensure that the implementation of Health & Safety and other legal requirements.
• To take part in staff recruitment and oversee the career development of staff.
• Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management

•Review and evaluate all data generated issues by different operations and quality control department and accordingly release or reject the raw, packaging and bulk materials or other objects under evaluation by the QC lab.
•Plan, coordinate and direct quality control program, design to ensure continuous production of products consistent with established standards.
•Develop and analyze statistical data and product specifications to determine present standards and establish proposed quality and reliability expectancy of finished products & raw material.
• maintains finished products & stability laboratory operational goals metrics for effectiveness and efficiency, as well as maintains and reports current compliance metrics and trend charts.
•Formulate and maintain quality control objectives to maximize product reliability and minimize costs.
•Direct, through intermediate personnel, workers engaged in inspection and testing activities to ensure continuous control over materials and products.
•Provide feedback and evaluations as needed and required for concerned departments.
•Troubleshoot laboratory instrumentation issues.
•Assist management of critical laboratory programs such as internal quality control program, measurement of uncertainty and analysis of all results.
•Provide technical expertise in support of the development of Q.C. testing methods & material specifications.
•Review validation of test methods validated by QC members after receiving from R&D.
•Ensure that qualified, skilled, and trained personnel and other resources are available.
•Assess the performance of QC Staff; recommend further training and practice to enhance their competency.
•Monitor training plan and matrix as required ensuring compliance and staff proficiency.
•Conduct all administrative duties including regulation of work hours, work shifts, overtime, etc.
•Act as a deputy for Quality Director to release the raw materials & packaging materials and finished products.
•Perform periodical employee appraisal for subordinates.
•Manage QC financial and budget aspects.
•Ensure the implementation of HSE regulation.
• To define with the agreement of the Vice chairman, the organizational structure and staffing of the Quality Control Group.
• To delegate responsibilities to those reporting as necessary and appropriately.
• To ensure that the implementation of Health & Safety and other legal requirements.
• To take part in staff recruitment and oversee the career development of staff.
• Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management

Responsible for Physical and chemical analysis of raw materials and finished products.
*Documentation and reporting of analytical results, deviations, suspected or out of specification results Preparation of COA according to raw material& products release specifications
*Responsible for sample pulling on the due date and testing the samples
*Good knowledge and practical working on high tech. lab instruments like HPLC, UV-VIS spectrometer, atomic absorption spectrophotometer and other routine work instruments for lab
And other routine analysis of pharmaceutical materials, water analysis and sustained release
* Reporting deviations, suspect results, OOS results, Lab variation results and any other required reports.
* Reporting any other event or observation concerning equipment, product, utility or any other relevant item in QC department
*Lecturing G.M.P training for newly employed staff .
*Preparation & execution for the internal audit program ( Self Inspection program)
Internal Audit Course
ISO 9001/2008 Awarness Course
cGMP
Good Documentation Practices
Train The Trainer Technically
Communication Skills Course
Team Building Course
Six Sigma Green Belt
ISO 9001: 2008 Lead Auditor Course
Motivational Leadership Course
Review, analyze & approve all inspections' reports to ensure that products are meeting present specifications.
Review, evaluate & approve quality actions related to non-conformity claims from plant.
Review, amend & approve Product Data Cards and production sheets of new / all products and upon changes for costing purposes, being a guideline for Production, planning and QC team.
Review & approve Material Reports for new RM / ORM from new / existing suppliers to ensure that production / process / product specifications are either better or similar to current standards.
Evaluate & train Quality Control team members to increase their level of know how.
Ensure maintenance & calibration of product related measuring equipment to ensure accurate measurements and readings.
Update, improve & maintain the Quality Control Documents, Procedures, Work instructions & Reports.
Evaluate and follow up on corrective / preventive action plans related to non-conformity and customer complaints.
Guide train and coach quality control team members for the best handling of quality issues.


 Perform the testing for raw materials, RO & purified water, semi finished products, finished product and stability samples.
 Test to be comply with local methods and specification as per SOP, BARs & RMA or pharmacopoeia methods.
 Sample collection for cleaning validation.
 Preparation of standard volumetric solution used for analysis.
 Perform calibration and maintenance of certain laboratory equipment as assigned.
 Inventory check and ordering of chemical and glassware as required.
 On time complete training curricula assigned in My-Learning or QMS training and provide the training to the staff where it is required.
 Maintain the Data record and entree in all QC related documents and files.
 Adhering to the OOS procedure and documenting investigations as required.
 To provide support to PPR by providing trend results for critical product (release) parameters, OOS investigation reports, providing laboratory equipment validation status and analytical method status.
 Identify any risk and escalate to the line manager, where applicable.
 Following and sustaining GLP standards for all lab activities.
*Review batch records of stability protocols for validation and commercial batches, cleaning validation protocols and process validation/evaluation protocols.

Good knowledge and practical working on:
*High performance liquid chromatography HPLC*Gas Chromatography GC
*U.V spectrophotometer *Atomic absorption spectrophotometer
*F.T.I.R spectrometer *dissolution & controlled release apparatus
And other routine analysis of pharmaceutical materials, water analysis and sustained release