Senior Quality Assurance Job Listing at UPS in Zona Industriale, Lombardia (Job ID 064539)

Description

Senior Quality Assurance

KEY RESPONSIBILITIES

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

• 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.