08 ott - Italia
H.Essers
Are you ready to harness your passion for quality in the dynamic role of Responsible Person? Discover below the challenges and rewards that come with this role at H.Essers.
YOUR CHALLENGES
As Responsible Person, you ensure compliance with:
• GDP regulations for human and veterinary medicinal products
• Legislative Decree 219/2006
• EU GDP Guidelines (2013/C 343/01)
• Ministerial Decree 6 July 1999
• Legislative Decree 218/2023
• EU Regulation 2021/1248
Quality Management
• Investigate quality issues and regulatory questions.
• Perform risk assessments and Quality Risk Management activities.
• Analyze data and propose corrective and preventive actions.
• Prepare and maintain quality documentation.
Reporting & Management Support
• Prepare reports, analyses and recommendations.
• Present findings to management.
• Contribute to Management Reviews and quality performance monitoring.
Project Management
• Support quality and compliance projects.
• Define project scope and timelines.
• Participate in project meetings and implementation activities.
Training & Continuous Improvement
• Deliver GDP/GxP training to employees.
• Keep up to date with regulatory developments.
• Support continuous improvement initiatives.
• Review and improve quality processes and procedures.
Stakeholder Management
• Act as the main quality reference point for internal departments.
• Interface with customers, suppliers and regulatory authorities (e.g. Ministry of Health, AIFA).
• Support business operations with quality and regulatory advice.
YOUR TALENTS
• Analytical thinking
• Problem-solving mindset
• Collaboration and teamwork
• Advisory and influencing skills
• Continuous learning attitude
• Strong communication skills
Education Requirements
Mandatory degree in:
• Pharmacy
• Pharmaceutical Chemistry and Technology (CTF)
• Chemistry
• Industrial Chemistry
Additionally
• Eligible for registration with the relevant professional body.
• Eligibility and willingn
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