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Primary Location: FORMELLO, Italy, Job ID R22002285

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.

Job Description:

JOB PURPOSE AND KEY RESPONSIBILITIES

  • 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.
  • Provide support to ensure compliance with local and regional legal requirements and regulatory authorities.
  • Has responsibility and authority to maintain an adequate organizational structure within their respective facilities, departments, and/or functional group(s).
  • Makes recommendations to RP/QP, Sr. Manager, Director, Global Healthcare Compliance.
  • When delegated to do so by RP, decides on the final disposition of finished products, returned, rejected, recalled, or falsified products.
  • Conducts Management Reviews, or ensures Management Reviews are conducted at defined intervals for Healthcare facilities/departments within their respective area of responsibility.
  • To promote a “quality” culture within the company.
  • To provide support for investigation into non-conformances and customer complaints.
  • To approve changes related to the applicable facility.
  • To follow-up on all Corrective Actions and Preventive Actions (CAPAs).
  • To be focused on the management of the authorized activities and the accuracy of the records.
  • To collaborate with the Qualified Person (QP)/Responsible Person (RP) to perform urgently all the operations during a pharmaceutical products recall.
  • To ensure the customer complaints are managed efficiently.
  • To ensure that customers and suppliers are approved.
  • To participate and assist in supplier audits and provide evaluation of suppliers.
  • To participate and follow up in Regulatory Compliance Reviews (RCR audits)
  • To ensure the operations taken place in the warehouse are performed according to the approved SOPs and/or work instructions in accordance with ISO 13485 standards and in compliance with EU GMP and EU GDP guidelines.
  • To follow up and control of the ambient conditions in order to ensure that the correct storage conditions for the products are maintained.
  • To collaborate with the QP/RP with regards to transport temperature monitoring when applicable.
  • Initiate/ attend Quality Management System Review meetings and present facility compliance metrics.
  • To hosts audits and acts as an Inspection Coordinator for regulatory agency inspections.
  • Monitor, conduct and coordinate self-inspections to ensure compliance with GMP, GDP andISO 9001 and 13485 requirements.
  • To participate and follow up with client audits to identify issues and mutually agree on the solutions.
  • To participates and follow up with agency audits to meet respective regulatory requirements.
  • To review (and where applicable approves) policies, procedures, validation protocols, reports, work instructions, forms and regulations with internal/ external clients to determine specialized requirements and ensure compliance.
  • To use existing career development process and tools with some assistance to monitor employee development; provides feedback to direct reports and peers on job skills and personal behavior; identifies employees’ areas of strength and developmental needs; recommends training opportunities for others with some guidance; assists in providing developmental suggestions to employees that align with their goals.
  • To provide direction to the Facility/Department Healthcare Compliance (QA) Specialists.
  • To oversee the tracking and reporting of required employee training for the facility/ department to ensure compliance.
  • When delegated to do so by Healthcare Compliance (QA) Management, RP/QP, provide assistance in external audits

KNOWLEDGE AND EXPERIENCE

  • Education level: Master’s Degree in Pharmacy.
  • Good English in speaking and writing
  • Good knowledge of Microsoft Office
  • Experience with ISO 9001 standards and
  • Experience with ISO 13485 standards is an advantage.
  • Knowledge of GMP and/ or GDP guidelines is an advantage.
  • Required minimum 4 years of experience in quality

Skills:

  • Good Communication skills to motivate team and to support internal/ external customer
  • Good analytical skills.
  • Good in People Management skills.
  • Flexible in working hours.
  • Ability to prioritize decisions which may have a significant risk for the company.
  • Identify potential gaps in the processes and make recommendations for possible improvements.
  • Identify and eliminate barriers to get an effective risk management and risk assessment.
  • Initiation and Co-ordination of improvement projects throughout the company.
  • Implementation of new processes having a quality critical impact on the business.
  • Knowledge of electronic Quality Management System and/or Warehouse Management System (WMS, GWS etc.) is an advantage.


Employee Type:

Permanent


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