Freelancer profile translated to English.
Back to original languageAbout Siham
Senior Consultant in Qualification & Validation / CSV, I support players in the pharmaceutical industry in the compliance and validation of their computerized systems and equipment according to GMP, 21 CFR Part 11, and Data Integrity principles.
I am involved in the entire project lifecycle, from requirements definition to production release and maintenance in a validated state: definition of validation strategies, writing of URS/FS, risk analyses, writing and execution of IQ/OQ/PQ/MQ protocols, management of Change Controls, deviations, anomalies, and CAPAs.
My added value lies in a dual operational and strategic expertise, strong documentary rigor, and the ability to secure implementation, migration, and upgrade projects in a regulated environment.
French
Native or bilingual
English
Fluent
Arabic
Native or bilingual
Can work on-site
Paris (up to 50km), Versailles (up to 40km), Vélizy-Villacoublay (up to 40km)
Experience
- IPSENSenior CSV ConsultantPHARMACEUTICALS INDUSTRYJanuary 2025 - Today (1 year and 7 months)Paris, France
- Carried out the decommissioning project for ICMUS production lines, managing the shutdown of systems in compliance with GMP requirements and applicable validation procedures.
- Performed data migration qualification for systems: LENEL, SmartVUE, EMPOWER, BMS, and ComplianceWire, including preparation, execution, and monitoring of tests, as well as drafting the quality documentation necessary for the validation of computerized systems.
- Executed validation activities for the ETQ / Quality Connect enhancements, in collaboration with business teams, monitoring action progress, managing non-conformities, and drafting associated quality documentation.
- Conducted the full validation of the Power BI LIMS solution: drafted quality documents (VP, URS, risk analyses, test specifications, validation protocols, and reports), executed tests, managed anomalies, and tracked actions to closure.
- Validated a temperature monitoring tool for shipment activities with the Supply Chain teams, including functional tests, document review, and drafting quality documents in compliance with Data Integrity requirements.
- Executed validation activities for an EHS & Sustainability tool, including migration activities, drafting quality documentation, and monitoring validation tests.
- Performed routine activities related to serialization via the Unicity - Tracelink tool: tool administration, preparation and execution of tests in a validation environment, anomaly investigations, and activity reporting.
- SanofiEquipment and Computerized System Qualification ConsultantPHARMACEUTICALS INDUSTRYMay 2022 - September 2024 (2 years and 4 months)Val-de-Reuil, FranceCold Room Qualification:
- Executed the qualification project for five cold rooms following the replacement of semi-automatic refrigeration units, including IQ/OQ/PQ activities and validation of the connection of new temperature, relative humidity, and pressure sensors to the IV TRACER and GTC systems.
- Performed the entire qualification cycle in compliance with GMP requirements: drafted quality documents (URS, risk analyses, Qualification Plan, IQ/OQ/PQ protocols, and reports), executed tests, monitored deviations/FAC, and implemented action plans until closure.
- Coordinated project activities with several departments: Metrology, New Works, Maintenance, and operational teams, with regular reporting to project and business managers.
Biological Inactivation System (RIB) Validation:- Executed the validation project for the biological inactivation system of the rabies vaccine manufacturing building, including drafting quality documentation (URS, risk analyses, Qualification Plan, protocols, and reports), test execution, and drafting decontamination cycle development protocols and reports.
- Performed environmental risk analyses and drafted associated environmental protocols in compliance with quality and regulatory requirements.
Isoflex Isolator Qualification and Validation:- Premises qualification,
- Interlocking systems qualification,
- New ACP points qualification,
- Decommissioning of old isolators and ensuring equipment transfer.
- Executed FAT/SAT activities, drafted associated quality documents (URS, risk analyses, Qualification Plan, qualification protocols, and reports), executed tests, and monitored anomalies until their closure.
- SANOFICSV ConsultantPHARMACEUTICALS INDUSTRYJanuary 2022 - May 2022 (4 months)Vitry-sur-Seine, FranceQualification and Validation of BATCH REPORT FIT AND HETP
- Drafting validation plans.
- Performing risk analyses.
- Drafting IQOQ test protocols/cases.
- Executing and verifying IQOQ tests.
- Monitoring and closing anomalies.
- Drafting IQOQ/AFD/AFU reports.
- Drafting traceability matrices.
- Archiving qualification files.
- Reporting on the progress of qualification activities.
- Drafting periodic reviews.
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Education
- Specialized Master, Specialized Master in Quality, Safety, and Environmental ManagementCESI2018
- Master 2 (M2), Food Conservation and PackagingENSAIA - National School of Agronomy and Food Industries2016