QA/ GMP Section Head
Pharma International Company
مجموع سنوات الخبرة :11 years, 11 أشهر
- Manage QA/GMP Compliance staff for the GF Plant
- Approve documents generated by QA/ GMP Compliance team and any related documents generated by company’s departments.
- Perform trainings for QA/ GMP Compliance and PIC employees as per the training system
- Perform internal audits on PIC departments as per the annual plan
- Improve and develop QA/ GMP Compliance documents as per the best practices and global guidelines
- Be aware for any updates on the global pharmaceutical guidelines and share them with related employees within PIC
- Lead the team for the preparation of any inspections by authorities (both direct and distance inspections)
- Part of the team participated for the restoration of the GF plant and warehouses after a fire incident; including:
o Impact assessments for the non-affected areas including the warehouses and the available stock
o Restoration of the plant from the fire (mutual work with external outsourced global specialized company)
o Re-design of the plant for more compliance for the manufacturing rooms (MAL and PAL), GRP Panels for walls and walkable ceiling, material flow, personnel flow, commissioning of new machines and AHUs
o Close the related deviation including the root cause, CAPAs and impact assessments
o Prepare the needed documentation and discuss with the authorities to resume the manufacturing
- Part of the team participating in the installation of Electronic Quality Management System (eQMS) including the following modules:
o Document Management System (DMS)
o Training Management System (TMS)
o Supplier Qualification Management (SQM)
o Change Control (CC)
o Quality Event (Deviation)
o Complaint
o CAPA
o Audits (Internal and External)
Duties include:
- Lead and perform the Quality Management System (QMS) audits on all departments to ensure the compliance and effectiveness of systems and procedures
- Lead and perform external audits on packaging materials suppliers as per annual program
- Generate, review and approve systems, procedures and SOPs against the global guidelines (WHO, European Guidelines, CFR Part 210 and 211 … etc.)
- Participating in closing deviations and customer complaints with the proper corrective/ preventive actions
- Perform Quality Risk Management (QRM) as per ICH Q9 Guideline.
Duties in addition of Quality Compliance officer duties include:
- Perform proper training for employees
- Review and check data generated by compliance team.
- I was a member of the compliance team for hosting the FDA inspection (July-2016)
Duties include:
- Receipt, handling of complaints and preparing the complaints trending report
- FDA System Audit: Annual audit is done for the FDA six systems
- External audit for pest control and stores contractors
- Responsibility for hosting all regulatory authorities inspections (FDA, GCC,
JFDA...etc.) including preparation for the audit and follow up the implementation of any observations
- Prepare and review the final Annual Product Review Report (APR) after receiving all departments entries
- Review and approve the trending reports of temperature and humidity chart recorders, DDC and data loggers
- Generate, Review and approve Standard Operating Procedures (SOP)
- Handling of Recalls and Mock Recall exercise
- Prepare the Site Master File (SMF)
- Evaluate and document the triggering events with the related departments and Quality Unit management (e.g. customer complaints, Stability test failures ... etc.) regarding the necessity to initiate field alerts (submitted to FDA)
- Follow up on opened CAPA related to Compliance department
- Handling finished product/ semi-finished product claims
- Submit field alert reports received from related departments after approved by quality unit management to FDA
- I was working on the cleaning validation project including implementation and re-evaluation
- I was a member of the compliance team for hosting the FDA inspection (June-2015)
QA System Engineer (Feb\2013-Dec\2013):
- Systems Improvement
- Internal QMS Audits
- Generate, Review and approve Standard Operating Procedures (SOP)
- Customer Complaints Handling
- Bill of Materials (BOM) Preparation and Control
QA\IPC in Packaging Area (Jul\2012-Feb\2013):
- GMP inspection in the packaging area
- Line clearance checking
- In-process sampling during the secondary packaging processes
- Packaging batch record review
- Finished product inspection before release.
Training course at Hikma Pharmaceuticals between May-Jul 2011.