QA Validation Senior Specialist
Alandalous for pharmaceutical industry
Total years of experience :7 years, 6 Months
QA Validation Senior Specialist| Al-Andalous
6- October - Giza - Egypt (August 2020 - Current)
- Developing & preparing validation documentation for departments & projects
(master plans, protocols & reports) as per company policies & regulatory
guidelines.
- Follow up and Evaluate for Process validation, cleaning validation,
Qualification, holding time, Thermal mapping, and Computerized System
Validation activities.
- Implement, and Improve for Validation Master Plan.
- Verifying equipment and systems to be qualified.
- Coordinate the qualification and calibration activities with the appropriate
individuals (the third party) and departments.
- Evaluate deviation that may occur during any validation & qualification activities.
- One of cross function team who responsible for batch record review against
the validated status.
- All the prepared documents reviewed and approved by internal and external
auditor ex (EMA, WHO, SFDA, and EDA)
- Supported department leadership in implementing new policies, procedures and
controls.
- Identified areas in need of critical improvement and implemented strategies to
achieve targets.
- Verified accuracy and effectiveness of reporting processes, effectively using
Microsoft Excel to track and model data for management review.
- Conducted independent technical reviews of current processes and records to
proactively identify and correct process and system issues.
- Drove change through quality-oriented strategies to help operations accomplish
ambitious short- and long-term goals.
- Attended training programs to deepen professional skillset and assisted in
training fellow store associates on existing and new training programs.
- Followed all company policies and procedures to deliver quality work.
QA Validation Specialist| Rameda Pharmaceutical
6- October - Giza - Egypt (August 2018 - July 2020)
(Liquid, Solid “Capsule, Tablet, Sachets, Powder filling, Eye-Drops, WFI,
non-sterile penicillin, sterile and non-sterile cephalosporin)
Implementation and follow up of validation projects such as:
- Developing & preparing validation documentation for departments & projects
(master plans, protocols & reports) as per company policies & regulatory
guidelines.
- Follow up and evaluate for validation activities (Process validation, Cleaning
validation, Holding time, & Thermal mapping)
- Prepare, Implement, and Improve for Validation Master Plan
- Attended training programs to deepen professional skillset and assisted in
training fellow store associates on existing and new training programs.
- Followed all company policies and procedures to deliver quality work.
(Liquid, Solid “Capsule, Tablet, Sachets, Powder filling, Eye-Drops, WFI,
non-sterile penicillin, sterile and non-sterile cephalosporin)
-Responsible for the routine work in the quality assurance department as per
company policies and department SOPs.
-Reviewing Batch Record & Quarantine and Responsible for Batch Release
-Able to Investigate deviations and Complaints with other Departments
-Able to follow up on Dispensing, preparation, Filling, and Packaging processes
-Monitoring the production area (non-sterile)
-Document control.
Supported department leadership in implementing new policies, procedures and
controls.
-Led projects by coordinating schedules, organizing resources and delegating
work to meet deliverable and timeline requirements.
-Verified accuracy and effectiveness of reporting processes, effectively using
Microsoft Excel to track and model data for management review.
-Perform the analysis by using manual and automatic techniques.
Production Specialist| Organo for Pharmaceutical
El-Obbour City - Cairo - Egypt (May 2017 - July 2017)
(Liquid, Solid “Capsule, Tablet, Sachets, Powder filling)
-Documented deviations in procedures or appearance on production batch sheets
for management review.
-Monitored production line for unsafe behaviors or incorrect techniques and
worked with managers to resolve problems.
-Maintained equipment in good working order by checking settings and operation,
troubleshooting problems and completing basic repairs.
-Assisted with maintaining good manufacturing practices on production line.