Youssif El-kenany

My objectives are to learn more skills and gain more experience, be a productive member in the organization and create a harmony with other divisions within the organization.

• Review & update of Site Validation Master Plan & Related Annexes.
• Follow up Execution of all validation / Qualification activities:
• Facilities Qualification
• Equipment / Systems / Utilities Qualification (URS/FAT/SAT/DQ/IQ/OQ/PQ)
• Manufacturing process validation
• Holding Time studies (Bulk and cleaning).
• Cleaning Method validation
• Computer system validation
• Transport validation
• Building Qualification
• Follow up Execution of Calibration program and execution of calibration plans including execution of thermal mapping studies
• Review & approve of validation / Qualification reports & Related Annexes.
• Review for all standard operating procedures related to the validation activities.
• Ensures that all activities in his unit are done according to Approved Validation Master Plan, relevant Who, cGMP and ISO standards.

• Date of Birth: 05/02/93
• Nationality: Egyptian
• Marital Status: Single

GxP Computer System Validation:

• Expertise in validation on of enterprise-wide Quality IT systems using established Computer System Validation on (CSV) methodology such as GAMP5 and FDA guidelines.

• Exposure in Computer System Validation Life Cycle ‘V’ model, Waterfall and Agile methodology.

• Experience with validaion/ testing tools like HPALM, qTest, JIRA, etc.

• Providing training to Validaion resources on CSV approach based on project.

• Preparation, Review and Authorization on of Validation on Deliverable like GxP assessment, User

Requirement Specification ons (URS),Compliance Analysis, Compliance Plan, Traceability Matrix, Functional onal Specification on, Design Specification, Compliance Summary Report, IQ/OQ/PQ Test Protocols & Reports, SRC, etc.

• Highly proficient with all the phases of SDLC (System Development Life Cycle) process.

• Handling of Change Management, Defect Management, CAPA Management, Business Process

Management, User Story Management, Risk Assessment, 21 CFR Part 11 Assessment etc.

• Participation n CAB meeting ,User Story Review Meeting , Daily Stand-Up Meetings, etc.

• Periodic Evaluation on of Computer Systems against 21 CFR Part 11.

• Implementation on of IT Security Controls to the GxP Systems in the facility.

• Conduct of Internal Quality Audits and follow up audits to ensure the compliance with Regulation ons.

• Routing and Approving validation on deliverables document in Adobe sign.

JIRA, qTest, Asset Management, TRU Vault, Tru Enovia, SOLMAN, DAISY, SAP, One Identity Manager, EDMS, Trackwise, LMS, Cipdox, Complinace-wire, Summit, LIMS, MES, HMI, etc.

Track-wise, ERP, MES, Mercury SAP migration on project (ECC), SAP-LIMS Interface project, SAP (MM, QM&PP), LMS, eDMS.