Irene Zanetti
Gharghur
Summary
Quality management professional equipped to drive and enhance operational excellence. Skilled in quality assurance, process improvement, and regulatory compliance. Strong emphasis on team collaboration and adaptability to changing needs. Known for reliability, strategic thinking, and achieving measurable results.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Head of Quality Unit/ Qualified Person/Regulatory Affairs Manager
Kelix Bio (Malta) Ltd. (former Chemi Pharma Ltd.)
11.2021 - Current
- Promoted quality assurance strategy across departments to ensure operational consistency.
- Executed batch release functions as Qualified Person, maintaining compliance with industry standards.
- Directed quality assurance and quality control activities to uphold acceptance criteria.
- Streamlined product transfer activities, enhancing overall operational efficiency.
- Developed and implemented regulatory strategies for both new and existing products.
- Provided regulatory guidance to ensure departmental compliance across all operations.
- Led inspections for Health Authorities including EU, US FDA, and Libya.
Qualified Person
Panaxia Pharmaceuticals Malta (Operations) Ltd.
11.2020 - Current
- Executed batch release processes for cannabis drug products in compliance with regulations.
- Performed activities related to responsibilities of Qualified Person for product oversight.
- Ensured adherence to quality standards during batch release procedures.
- Collaborated with production teams to streamline release workflows and minimize delays.
- Advise on and coordinate the preparation of documents required for regulatory submissions
Quality Assurance Manager and Qualified Person
Chemi Pharma LTD
01.2018 - 11.2021
- Designed and managed Quality System, Regulatory Affairs, and Quality Assurance functions for optimal resource deployment.
- Ensured compliance with group policies, quality standards, and international GMP regulations.
- Oversaw inspections by US FDA and Health Authorities to maintain operational integrity.
- Conducted batch release processes in alignment with Qualified Person responsibilities.
Qualified Person and Quality Assurance Systems coordinator
Fresenius Kabi Italia s.r.l.
07.2010 - 12.2017
- Oversaw batch release processes and fulfilled Qualified Person responsibilities.
- Managed documentation for quality system, including Quality Manual and SOPs.
- Coordinated internal and external audits to ensure compliance with regulations.
- Evaluated supplier qualifications and maintained surveillance for quality assurance.
- Led quality metrics analysis, KPI tracking, and personnel training initiatives.
- Participated in inspections by Italian Medicine Agency and Certified Bodies.
- Addressed deviations found during inspections and managed data integrity protocols.
- Contributed to OPEX team efforts to enhance operational efficiency.
Quality Assurance Manager and Regulatory Affairs
Biomedica Foscama Industria Chimico-Farmaceutica S.p.A.
07.2009 - 07.2010
- Produced and marketed medicines for human use, ensuring compliance with regulations.
- Managed SOPs, deviations, claims, changes, validations, and personnel training.
- Conducted internal and external audits to verify adherence to industry standards.
- Evaluated regulatory aspects for registrations, renewals, reviews, and variations.
Quality Assurance Manager
Vaxxinova - IZO SPA
08.2007 - 06.2009
- Oversaw production and marketing of veterinary medicines and vaccines, ensuring market readiness.
- Managed SOPs, deviations, claims, and changes to uphold compliance standards.
- Developed and executed validation plans to guarantee operational integrity.
- Conducted personnel training to improve team competencies and performance.
- Executed internal and external audits, maintaining rigorous quality standards.
- Led Product Quality Reviews to evaluate product integrity and compliance.
Quality Assurance Assistant, Regulatory Affairs Assistant
Recipharm
03.2005 - 07.2007
- Managed evaluations of regulatory aspects for registrations and advertising material authorization.
- Conducted thorough reviews of batch records and analytical procedures.
- Developed standard operating procedures and process validations to enhance compliance.
- Collaborated on deviation management and change control processes for operational improvements.
- Evaluated analytical methods validation to ensure accuracy and reliability of results.
- Established and assessed Drug Registration Dossier for submissions and renewals.
- Oversaw analytical batch record management to maintain quality assurance standards.
Education
Master's Degree - Pharmaceutical Chemistry and Technologies
University of Padova
11.2004
Skills
- Languages: Italian (native), English (advanced), French (proficient)
- Communication skills: Effective verbal and written communication
- Organizational skills: Leadership, project management, problem-solving
- Computer skills: Proficient in Microsoft Office, TrackWise, Pragma, Adiuto, Minitab, DOT
- Master in global Operational Excellence with AI and emerging technologies
- Award in Pharmacovigilance (Level 6)
- Qualified Auditor ISO 9000 (TÜV SUD)
- Qualification to the functions of Qualified Person according to Decree of Italian Ministry of Health n° aIDT-90/2008 from 10162008
- Qualification to the functions of Qualified Person according to Maltese Laws for sterile (liquids, solids), Oral (liquids, solids) and semisolids
- Registered Qualified Person and in the Register of Pharmacists as from 10th November 2021 no 1610
Certification
- Enrolment in the Professional Register of Pharmacists Association of Verona (no. 2518 from 2012-02-16)
- Qualification to the functions of Qualified Person according to Decree of Italian Ministry of Health n aIDT-90/2008 from 2008-10-16
- Qualification to the functions of sterile liquids and solids and oral liquids Qualified Person according to Maltese Laws
- Registered in the Register of Pharmacists as from 2021-11-10 no 1610
- Participation to ISO 9000 Internal Auditor Course with passed final examination (TUV SUD)
PERSONAL SKILLS
MOTHER TONGUE: ITALIAN
OTHER LANGUAGES: ENGLISH - GOOD USER, FRENCH - PROFICIENT USER
Timeline
Head of Quality Unit/ Qualified Person/Regulatory Affairs Manager
Kelix Bio (Malta) Ltd. (former Chemi Pharma Ltd.)
11.2021 - Current
Qualified Person
Panaxia Pharmaceuticals Malta (Operations) Ltd.
11.2020 - Current
Quality Assurance Manager and Qualified Person
Chemi Pharma LTD
01.2018 - 11.2021
Qualified Person and Quality Assurance Systems coordinator
Fresenius Kabi Italia s.r.l.
07.2010 - 12.2017
Quality Assurance Manager and Regulatory Affairs
Biomedica Foscama Industria Chimico-Farmaceutica S.p.A.
07.2009 - 07.2010
Quality Assurance Manager
Vaxxinova - IZO SPA
08.2007 - 06.2009
Quality Assurance Assistant, Regulatory Affairs Assistant
Recipharm
03.2005 - 07.2007
Master's Degree - Pharmaceutical Chemistry and Technologies
University of Padova
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