UPS Job - 35787564 | CareerArc
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Company: UPS
Location: Zona Industriale, Lombardia, Italy
Career Level: Mid-Senior Level
Industries: Transportation, Logistics, Trucking

Description

Senior Quality Assurance

KEY RESPONSIBILITIES

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

MANAGEMENT AND MAINTENANCE OF QUALITY DOCUMENTS ANDPROCEDURES

• Own/ write/ review Procedures, Work Instructions, andtechnical documents;

• Performs training programs in SOPs, work instructionsand regulatory topics;

• Management of Non conformities;

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

• Scheduling, preparation and perform internal andexternal audits;

• Management of Change Controls;

• Ensure equipment calibration and maintenance programare 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 andregulatory agencies audits;

• Collaborate to ensure that the vendors are properlyapproved;

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

GDP REGULATORY

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

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

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

• Supervises the temperature monitoring through all steps;

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

GMP REGULATORY

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

• Collaborate with the Qualified Person to ensure thatall the checks and tests, including sampling or additional checks have beenperformed;

• Collaborate with the Qualified Person to ensure thatall necessary documentation regarding production and quality control, has beendeveloped and approved;

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

• Reviews of batch records.

KNOWLEDGE AND EXPERIENCE

Education level:

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

• Professional authorization according with Italianlegislation (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 companiessuch as manufacturer/ laboratories/ distributors of pharmaceutical products.

Skills:

• Ability to prioritize decisions;

• Good organizational skills;  

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

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

• Flexible in working hours;

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

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



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