Quality Control Assistant Manager
pharma International
Total des années d'expérience :33 years, 5 Mois
Technical Support for all purchasing issues
1. Pharma International Company Nalchic / Russia
March 2011- Till now
Quality Control Manager
Prepare Standard Operating Procedures, Specifications and any documents that have impact on product quality
Ensure that the required initial and continuing training of Q.C Labs. Personnel is carried out and adapted according to needs
Ensure that all necessary testing is carried out according to approved written procedures
Ensure that the department is fulfilling the company policy & targets
Monitor compliance with the requirements of cGLP and cGMP
Ensure that Analytical Methods and Specifications are revised and updated.
Issue purchase orders for the labs (chemicals, spare parts, tools )
Organize Q.C Program according to Production department.
Follow up and maintain filing all documents related to instruments, analysis and employees.
Maintain all the documents in the labs.
Check the instructions related to Q.C. operation and ensure their strict implementation.
Approve Analytical Reports and issue Certificates of Analysis.
Release or reject batches of Raw and Packaging Materials or Finished Product
Approve or refuse a laboratory Raw Data Investigation of O.O.S report
June 2009 - February 2011
Acting Quality Control Manager
Check Standard Operating Procedures, Test Procedures and any documents that have impact on product quality.
Prepare Q.C Labs. Budget and follow their implementation.
Maintain the Q.C Labs. Personnel in good moral.
Set and follow up work programs with supervisors of QC labs
Ensure that the required initial and continuing training of Q.C / I.P.C Labs. Personnel is carried out and adapted according to needs.
Ensure that all necessary testing is carried out according to approved written procedures.
Check Test Methods and other Quality Control procedures.
Ensure that the appropriate validations are done.
Ensure that the department is fulfilling the company policy & targets
Monitor compliance with the requirements of cGLP and cGMP
Ensure that Analytical Methods and Specifications are revised and updated.
Check purchase orders for the labs (chemicals, spare parts, tools)
Organize Q.C Program according to (Material and Production) departments.
Prepare Evaluation Reports for the employees in the department.
Manage Q.C employee's affairs.
Ensure the safety matters in labs.
Follow up and maintain filing all documents related to instruments, analysis and employees.
Maintain all the documents in the labs.
Check the instructions related to Q.C / I.P.C Lab. operation and ensure their strict implementation.
Approve Analytical Reports and Certificates of Analysis.
Manage and control the daily activities in the labs.
Release or reject batches of Raw and Packaging Materials or Finished Product.
Approve or refuse a laboratory Raw Data Investigation of O.O.S report
May 2007-May 2009
Head of Quality Control.
Deputy of QC manager during his absence
Checking analytical reports and certificates of analysis for finished products and raw &Packaging materials
Write and check Standard Operating Procedures, Test Procedures and any documents that have impact on product quality.
Co-ordinate with R&D Department to write Specification to Raw and Packaging Materials.
Follow up, distribute and control the daily activities in the Q.C / I.P.C Labs. Through the supervisors.
Ensure that the required initial and continuing training of Q.C / I.P.C Labs. Personnel is carried out and adapted according to needs.
Ensure that all necessary testing is carried out according to approved written procedures.
Check Test Methods and other Quality Control documents.
Monitor compliance with the requirements of cGLP and cGMP.
Ensure that Analytical Methods and Specifications are revised and updated according to technical file and/or pharmacopoeia.
Participate in implementing, developing and following up the QC department budget for both human and technical resources.
Follow up the lab needs and prepare purchase orders (chemicals, spare parts, tools)
Set work programs with the supervisors after discussing priorities with QC Manager.
Ensure the safety matters in the lab.
Follow up filing of all documents related to instruments, analysis and employees by the supervisor.
Check the instructions related to Q.C / I.P.C Lab. operation and ensure their strict implementation.
2. Pharma International Company Amman / Jordan
June 1999-April 2007
Raw & Packaging Material Supervisor.
Supervise raw & packaging materials analysis according to approved specifications.
Participate in supervise finished product analysis according to approved test procedures
Participate in supervise In process control of finished product during production stages.
Participate in validation of purified water system according to current Pharmacopeias.
Participate in qualification of raw & packaging material suppliers according to approved systems.
Check all product packaging printed designs (packs, labels, insert, Al. foil, and Al. tubes)
Supervise preparing and analyzing working standards to be used in the QC Department.
Supervise updating test procedures and specifications according to current Pharmacopeias
Supervise calibrating and qualification of all instruments in the QC labs.
Supervise implementation of training programs for new and old employees in the QC department according to approved systems.
Prepare and check all analytical reports for Raw and packaging materials.
Establishing the quality control department specifications, systems, standard operating
Procedures, test procedures etc.
Establishing standard operating procedures for operating and calibrating instruments in the QC labs
Participate in performing IQ / OQ and PQ for new instruments in the QC labs
3. Al- Razi Pharmaceutical Industries Company Amman / Jordan
November 1997 - June 1999
Raw & Packaging Material Supervisor.
Establishing the raw & packaging material specifications, test procedures, forms, standard operating procedures.
Participate in performing IQ /OQ and PQ for new instruments in the QC labs.
Performing testing for finish products, raw & packaging materials according to approved specifications.
Participate in validation of purified water system according to current Pharmacopeias.
Establishing standard operating procedures for operating and calibrating instruments in the QC labs.
4. Pharma International Company Amman / Jordan
March 1997 - November 1997
Analyst in the Research & Development Stability lab.
Performing chemical & physical analysis for stress and room temperature stability batches according to approved procedures.
Perform analytical method developing and validation.
5. Dar Al-Dawa Pharmaceutical Company Amman / Jordan
August 1990 - February 1997
Chemical Analyst
Performing sampling and testing for raw materials.
Performing sampling and testing for finish products.
Perform inspection, sampling, testing of finish products in process control.
Perform purified water testing.
Prepare and standardize volumetric and test solutions according to pharmacopeias.
Prepare working standards according to approved systems.
High Diploma in Chemical Engineering Technicians, University Of Jordan /1986.