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Senior Quality Assurance

Primary Location: Via del Lago, n. 1 , Liscate, Milano - IT, 20060 Job ID 064539

Senior Quality Assurance


The ideal candidate must be the QP and RP back up for Liscate plant.


• Own/ write/ review Procedures, Work Instructions, and technical documents;

• Performs training programs in SOPs, work instructions and regulatory topics;

• Management of Non conformities;

• Follows up the CAPA actions in order to get them implemented on time;

• Scheduling, preparation and perform internal and external audits;

• Management of Change Controls;

• Ensure equipment calibration and maintenance program are met;

• Under the direction of the Healthcare Compliance (QA) Management, conducts Management Reviews;

• Provide support for validation activities;

• Collaborates in the reception of corporate audits and regulatory agencies audits;

• Collaborate to ensure that the vendors are properly approved;

• Assist with the implementation and maintenance of the Quality Management System in accordance with ISO 9001 and 13485 standards.


• Collaborates with the Responsible Person  to ensure that the recall process is properly managed;

• Collaborates with the Responsible Person to ensure that the return process are properly managed;

• Collaborates with the Responsible Person to ensure that compliance of the legislation related to narcotics and psychotropic are met;

• Supervises the temperature monitoring through all steps;

• Assures that all the processes regarding the warehouse activity (storage, vehicles inspection, products inspection, picking & Packing, etc) are performed according to approved procedures or work instructions and according the GDP and GMP regulations.


• Collaborate with the Qualified Person to ensure that GMP guidelines (annex 16EU) are respected;

• Collaborate with the Qualified Person to ensure that all the checks and tests, including sampling or additional checks have been performed;

• Collaborate with the Qualified Person to ensure that all necessary documentation regarding production and quality control, has been developed and approved;

• Collaborate with the Qualified Person to ensure that all quality inspections for pre-production, production and post-production have been carried out (e.g. line clearances, control of material to use, etc);

• Reviews of batch records.


Education level:

• Master degree and work experience to be qualified as QP;

• Professional authorization according with Italian legislation (Iscrizione all’albo);

• Good knowledge of English;

• Good knowledge of Microsoft Office.

Specialized Knowledge:

• Experience with ISO 9001 and/or ISO 13485;

• Knowledge of GMP and GDP;

• Required mínimum 2 years of experience in companies such as manufacturer/ laboratories/ distributors of pharmaceutical products.


• Ability to prioritize decisions;

• Good organizational skills;  

• Identify potential gaps in the processes and make recommendations for possible improvements;

• Implementation of new processes having a quality critical impact on the business;

• Flexible in working hours;

• Knowledge of electronic Quality Management System and/or Warehouse Management System (WMS, GWS etc.) is an advantage.

UPS is proud be an Equal Opportunity Employer and an Affirmative Action.

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