GDP Responsible Person
GDP Responsible Person
This role is in the UPS Healthcare Italy division which operates in the pharmaceutical logistics and distribution market, shipping from Formello (Rome) and Liscate (Milano).
Office: Liscate (Milan)
FUTURE YOU promises strong technical performance
Can you prove you’re capable of being responsible for GDP practices in front of the healthcare regulatory inspections regarding our activity of storage and distribution of medicinal products and active substances of medicinal products? You will receive the authority, recourses and the responsibility necessary to fulfil with
these responsibilities to ensure that our facility can demonstrate compliance to EU GDP and that the public service requirements are correctly met.
We’re offering a permanent contract to a skilled worker who wants to become our Responsible Person for UPS Healthcare facility in Liscate (Milan), with a good level of autonomy and continuous availability, that will manage the Quality Management System and will maintain the Wholesaler Distribution Authorization License and concerned GDP certification of the company.
If you show the correct capabilities and attitude, there could be the opportunity for you to grow your career and upskill on greater level within UPS. we’ll offer you a compensation package equal to the experiences you gain.
What you’ll do
• Control the compliance of the recall procedure, which should assure the effective execution with the properly urgency, of any recall order issued by the corresponding country specific Regulatory Agency.
• Control the correct application of any other interim measure ordered by the competent health authority and focus on the management of authorized activities and the accuracy and quality of records.
• Ensure that initial and continued training programs are followed.
• Ensure the functioning of the quality system and ensure to have the needed procedures for the correct development of his/her activities.
• Ensure relevant clients’ complaints are dealt with effectively to ensure compliance and the vendors and the clients are approved.
• Approve all the subcontracted activities which may impact Good Distribution Practices.
• Participate -to internal and external audits.
• Ensure the self-inspections are performed with the scheduled periodicity and any necessary corrective actions are taken in place.
• Keep appropriate records of any delegated duties to ensure compliance.
• Decides about the final UPS disposition of the finished products, returned, rejected, recalled or falsified products.
• Assess and approve, returns to saleable stock after verification that the returns were handled in compliance with EU GDP and EU GDP API.
• The RP ensure the compliance of any other requirement that national law imposes on certain products (Article 83 of Directive 2001/83/EC).
• Check the legality of the vendors that provide the medicines and the clients that receive them.
• Need to be informed about the complaints received, supervise the properly investigation and take the measures according to each case.
• Supervise the compliance with the special legislation about narcotics, psychotropic and other medicines subject to special control.
• Unload or review the information from temperature Data Loggers taken in the reception process.
• Establish process of temperature monitoring in transport based on a risk assessment focused on type of routes, transport schedules and intermediates platforms.
• Serve as a partner with health authorities and cooperate with them in implementing appropriate measures. Keeps and protects all the documentation related to the Distribution center authorization, as well as the established GDP documentation.
What you’ll get
• Permanent contract
• Competitive salary
• Excellent onboarding and ongoing training
• Plenty of opportunities to progress and grow thanks to our ‘promotion from within policy’.
What you’ll need
• We’re flexible, but ideally you will have at least a Bachelor’s Degree in Pharmacy/Chemistry/ Pharmaceutical Chemistry and Technology (CTF)
• You should have at least 3 years of experience within a company with advanced quality systems.
• You must have worked in companies as Quality Assurance and/or as Responsible Person.
• Experience with ISO 9001 and 13485 standards is a nice to have.
• You have strong Office skills and in particular on Excel and Power Point.
• Other than that, you’ll be an analytical problem solver who sets goals and stays focused on achieving them.
• You’ll also need strong oral and written English language skills.
How we recruit
UPS is committed to a policy of treating individuals fairly and recruiting, selecting, training, promoting and compensating based on merit, experience and other work-related criteria. We do not discriminate against any applicant based on age, race, religion, sex, disability, sexual orientation or gender identity.Apply Now