Francesca Menicucci
Lead Auditor
Experience
Dec 2022 - Present
3 years 2 monthsLead 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.
Jan 2021 - Present
5 years 1 monthParma, Italy
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.
Jan 2017 - Dec 2021
5 yearsParma, Italy
Quality Assurance Lead
GSK
- Led a team of QA in the development and implementation of comprehensive quality assurance strategies tailored to organizational needs.
Jan 2013 - Dec 2021
9 yearsParma, Italy
Quality Assurance Specialist
GSK
- Record quality assurance activities to maintain accurate documentation and manage quality of system.
- Management of quality deviation, changes, and CAPA.
Feb 2011 - Jan 2013
2 yearsSondrio, Italy
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.
May 2010 - Jan 2011
9 monthsPisa, Italy
Quality Assurance Specialist
Farmigea SPA
- Batch record review, review of standard operating procedures.
- Operation oversight.
- Deviation and change management.
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
Italian
NativeEnglish
AdvancedSpanish
ElementaryFrench
ElementaryEducation
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
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