Senior Quality Assurance
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.
• 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.
• 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
• 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.
• 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.
• 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.
Apply on company website