Francesca Menicucci
Lead Auditor
Experience
Lead Auditor
Intertek France
- Conduct supplier audits to ensure compliance with quality standards.
- Write comprehensive audit reports outlining findings and recommending actionable enhancements for customer.
- Conduct comprehensive review of CAPA plan for customer.
Quality Auditor
GSK
- Perform audit according to the audit plan.
- Develop comprehensive audit reports, detailing observations, implications, and recommendations for senior management.
- Led training sessions for junior auditors.
- Monitor ongoing compliance with internal policies and external regulations, providing periodic updates to management.
- Implement risk-based audit strategies to focus on high-risk areas, enhancing efficiency and coverage.
- Review internal controls and identified potential control system and process weaknesses requiring attention and resolution.
- Monitoring of the corrective action related to the audit findings.
Quality Assurance Lead
GSK
- Led a team of QA in the development and implementation of comprehensive quality assurance strategies tailored to organizational needs.
Quality Assurance Specialist
GSK
- Record quality assurance activities to maintain accurate documentation and manage quality of system.
- Management of quality deviation, changes, and CAPA.
Quality and Safety System Manager
Haemopharm Biofluids SRL
- Streamlined Quality and Safety Management System documentation, facilitating easy access and reference for all staff members.
- Evaluated and revised Quality and Safety Management System documentation, ensuring procedures align with standards.
- Oversaw compliance with Quality and Safety Management System in alignment with GMP and safety standards.
- Facilitated internal and external audits to ensure compliance with product and quality specifications.
- Training to staff.
Quality Assurance Specialist
Farmigea SPA
- Batch record review, review of standard operating procedures.
- Operation oversight.
- Deviation and change management.
Industries Experience
See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.
Experienced in Pharmaceutical (16 years) and Professional Services (3 years).
Business Areas Experience
The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.
Experienced in Quality Assurance (16 years) and Audit (5 years).
Summary
I am a quality-focused professional with over a decade of experience in audits and quality assurance. I specialize in thorough audits, CAPA plan reviews, and risk-based strategies that enhance process efficiency and compliance with industry standards.
I have built strong skills in documentation, stakeholder communication, and team collaboration. My background includes leading audit for Pharma and cosmetic GMP, ISO 13485 and 9001. I worked as Project Maneger for digital solutions inplementation.
Skills
- Audit Planning
- Compliance Monitoring
- Risk Assessment
- Internal Controls
- Documentation Management
- Capa Management
- Continuous Improvement
- Team Leader, People Managing
- Quality Assessment
Languages
Education
Almalaboris
Master of Science · Quality and safety System Management · Milan, Italy
University of Pisa
Bachelor of Science · Chemical and Pharmaceutical · Pisa, Italy
Certifications & licenses
Lead Quality Auditor Certification
Profile
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