QA Assistant Manager
European EgyptianPharmaceutical Industry (EEPI)
مجموع سنوات الخبرة :18 years, 8 أشهر
1- I responsible for GMP team for inspection and follow up for GMP compliance according to international slandereds of pharmacutical industries.
2- Responsible for Quality Management System documentation:
- Deviation and quality defect investigations.
-NCR/ CAPA system.
-Change control management.
-Complaint investigation.
-Recall procedures.
-Annual product review.
-Internal audit program.
3- Responsible for supplier qualification program.
4-Conduct an internal audit for GMPc, QMS, EHS and OHSAS systms.
5-Prform an external audit related to vendor audit for raw and packaging materials
(I perform many an On site audit on APIs supplies in China)
6-Prform an external audits related to tall manufacturing companies.
7-Partcipte in external audit as a member of audited team.(WHO, MHRA.Romania and DNDi).
8-As a member in QRM committe.
9-As a member in OHS committe.
10-As a member in EHS committe
Responsible for cGMP compliance team for daily inspection and follow up manufacturing areas
Responsible of QMS documentation : -
Deviation and quality defect investigation.
Change control system.
NCR/CAPA System and follow up.
Annual product review.
Internal audit program.
Complaints and Recall.
Responsible of Supplier qualification program.
Responsible of execution committee. (Raw materials, Packaging
Materials, Finished Products and Chemicals).
Responsible of MSDS issuing and distribution.
Assist Q A Director in all aspects of Supervision of GMP
compliance and employees.
Supervise QA team who carry out the detailed assessment of
products and their components at different stages of production
Perform manufacturing investigations-
Evaluate addressed deficiencies for potential impact on
compliance status while working with Manufacturing and/or QC
to correct any noted deficiencies/inconsistencies.
Ensure compliance with current Good manufacturing practices
(cGMP) around the entire facility, Company standard Operating
Procedures (SOPs), Good laboratory Practices (GLP), Good
Storage Practices (GSP), Good Documentation Practices (GDP)
and authority regulations and guidelines.
Evaluate CAPA responses to the assessment findings for
adequacy, including root cause and timelines.
Coordinate validation activities between internal departments.
Perform an internal audit related to (GMPc, QMS, EMS and
OHSAS) systems on all departments in plant. (Production, QC
labs, R&D, Utilities, Warehouses and distribution warehouses).
Perform an external audit related to vendor audit of :-
- Raw materials and packaging materials suppliers.
(I performed On Site Audits on three API Manufacturers in
China).
- Toll manufacturing pharmaceutical companies.
As a member in QRM committee.
As a member in Safety and Occupational health committee.
As a member in Environment committee.
As a member in Validation committee.
Participated in WHO audit and MHRA audit as a member in
audited team.
Participated in new ISO9001:2015 audit as a member in audited
team.
Follow up audits results to confirm corrective actions are
effective.
Ensure compliance with all company policies and procedures
including safety and environment rules and regulations.
Issuing and updating all SOPs related to GMP and QMS to be on
risky based.
Follow up of Qualification, Calibration and Maintenance plan for
all equipments, Utilities and balances.
Review and approve documentation of qualification (IQ, OQ.PQ)
of new equipment, facilities, and critical utilities including FAT
and URS document.
Train the QA (GMP team), and provide them with the documented
quality standards as guidelines for their day to day work.
Assess the performance of GMP team; recommend further
training and practices to enhance their competency.
As an internal trainer
1/2012 to 2/2014 as a Section Head.
- From 2/2014 up to now as an Assistant Manager.
Responsible for GMP compliance team for daily inspection on
manufacturing areas.
Responsible of QMS documentation : -
- Deviation and quality defect investigation.
- Change control system.
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.Bachelors degree of sciences department Chemistry-Botany