Qualified person - responsible person back-up (ckg-223)

Explore your next opportunity at a Fortune Global 500 organization. Envision innovative possibilities, experience our rewarding culture, and work with talented teams that help you become better every day. We know what it takes to lead UPS into tomorrow—people with a unique combination of skill passion. If you have the qualities and drive to lead yourself or teams, there are roles ready to cultivate your skills and take you to the next level. GDP/GMP This role is in the UPS Healthcare Italy division which operates in the pharmaceutical logistics and distribution market. Office: Somaglia FUTURE YOU promises strong technical performance . Can you prove you’re capable of being responsible for assisting with the implementation and maintenance of the Quality Management System in accordance with ISO 9001 and 13485 standards, and in compliance with the EU GMP and EU GDP Guidelines? We’re offering a permanent contract to a skilled worker who wants to become a Quality Assurance Specialist for UPS Healthcare facility in Somaglia (Lodi), with a good level of autonomy and continuous improvement, that will be part of a team involved in issues like compliance, licenses, non-conformances investigations and audit. If you show the correct capabilities and attitude, there could be the opportunity for you to grow your career and upskill on a greater level within UPS. What you’ll do: Provide support to ensure compliance with local and regional legal requirements and regulatory authorities. Provide support to ensure the license verification is performed for customers, suppliers and any other entities working within UPS facilities (Pharmacy, GMP Area, etc.). Provide training, ensure the training needs are met and coordinate the trainings for the staff. Monitor, conduct and coordinate self-inspections to ensure compliance with GMP, GDP and ISO 9001 and 13485 requirements. When delegated to do so by Healthcare Compliance (QA) Management or RP/QP, provide assistance in external audits. Participate and assist in supplier audits and provide evaluation of suppliers. Provide support for investigation into non-conformances and customer complaints. Create Change Controls for any significant changes and communicate them internally and to clients. Follow-up on all Corrective Actions and Preventive Actions (CAPAs). Assist in the maintenance of documentation in accordance with the EU GMP/ EU GDP Guidelines, and the relevant standards. Own/write/review Procedures, Work Instructions, and technical documents as assigned to do so. Ensure that the operations performed at the facility (reception, inspection receipt, storage, picking and shipping) are made in accordance with the approved procedures/work instructions and in compliance with the EU GMP/ EU GDP guidelines. Under the supervision/direction of the Healthcare Compliance (QA) Management, conduct Management Reviews. Provide support for validation activities. Ensure equipment calibration and maintenance program are met. Collect Temperature Data and monitor the temperature environmental conditions. Promote a “quality” culture within the company. What you’ll get: Permanent contract. Plenty of opportunities to progress and grow thanks to our ‘promotion from within policy’. What you’ll need: You will have at least a Bachelor’s Degree in Pharmacy/Chemistry/Pharmaceutical Chemistry and Technology (CTF). The Qualified Person (QP) requirement, as defined in Article 48 of Directive 2001/83/EC. The Responsible Person (RP) is designated by the warehouse distributor with Good Distribution Practice (GDP) license. You should have at least 2 years of experience in companies such as manufacturer/laboratories/distributors of pharmaceutical products, food and feed. Experience with ISO 9001 is required; experience with ISO 13485 is an advantage. Knowledge of GMP and/or GDP guidelines is a nice to have. You have strong Office skills, particularly in Excel and PowerPoint. Ability to prioritize decisions which may have a significant risk for the company, identify potential gaps in the processes, make recommendations for improvements, and eliminate barriers to effective risk management and risk assessment. Advanced 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 applicants. J-18808-Ljbffr

Location: casalpusterlengo, IT

Posted Date: 1/18/2025