Hayat Bouknine - Qualification & Validation Engineer – Equipment and Utilities
Experience
Qualification & Validation Engineer – Equipment and Utilities
SOPHARTEX
- Executed IQ/OQ/PQ for equipment and technical utility systems (HVAC, purified water, compressed air, clean steam).
- Managed and closed audit deviations and CAPA.
- Performed and tracked risk analyses (FMEA, criticality).
- Updated procedures and validation plans.
- Coordinated across departments and participated in audits.
Deputy Qualification Manager
CURIUM
- Created, reviewed, and approved IQ/OQ/PQ protocols and reports.
- Developed work instructions for new equipment.
- Monitored the site-specific validation plan.
- Validated computer systems (URS, RA, testing, deviations).
- Trained and supported teams.
Qualification/Validation Lead – Operational Quality Assurance
APTAR
- Developed and implemented the site-specific validation plan.
- Created IQ/OQ/PQ templates and updated procedures.
- Qualified and requalified equipment.
- Managed deviations and CAPA.
Qualification/Validation Consultant
SANOFI
- Led technical meetings and managed scheduling.
- Developed URS and IQ/OQ/PQ protocols and reports.
- Qualified cold rooms.
Qualification/Validation Consultant
GSK
- Prepared and executed FAT/SAT/VPL/IQ/OQ/PQ.
- Conducted risk analyses and managed CAPA and deviations.
- Qualified production equipment (filling line, labeling machine, reactors).
Environmental Qualification Technician
VALDEPHARM
- Qualification of HVAC, compressed air, nitrogen systems, LAF and lab exhausts.
- Environmental tests (particle classification, RH/T, HEPA tests).
- Development of procedures and handling deviations.
Filling Line Leader – Sterile Production
ASPEN
Production Support Technician
SANOFI
Visual Inspection Line Operator
SANOFI
Pharmaceutical Technical Assistant
Apotheke
Industry Experience
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Experienced in Pharmaceutical, Healthcare, and Manufacturing.
Business Area Experience
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Experienced in Customer Service, Quality Assurance, Production, and Operations.
Summary
Qualification and validation expert with over 10 years of experience in the pharmaceutical industry. Solid knowledge in GMP environments, equipment and utility qualification, as well as computer systems (CSV). Structured, audit-experienced professional with strong interface management skills.
Skills
- Qualification / Validation: Iq/oq/pq, Fat/sat, Risk Analysis, Csv.
- Quality Management: Deviations, Capa, Audits, Sops, Gmp, Iso 9001:2015.
- Project Management: Planning, Cross-department Coordination, Kpi Tracking, Reporting.
- Tools: Geod, Gibraltar, Phenix, Qualipso, Iv Tracer, Preference, Domava.
- Methods: Fmea, 5w2h, Pdca, 5s, Brainstorming.
Languages
Education
TSPCI · Pharmaceutical and Cosmetic Industry
BP – PTA · PTA
Bachelor in Biology · Biology
Statistics
Experience
Global Experience
Expertise
Qualifications
Profile
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