UPS Senior Quality Assurance in Liscate, Italy
Senior Quality Assurance
The ideal candidate must be the QP and RP back up for Liscate plant.
MANAGEMENT AND MAINTENANCE OF QUALITY DOCUMENTS AND PROCEDURES
• 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.
KNOWLEDGE AND EXPERIENCE
• 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.
• 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.
Company: UNITED PARCEL SERVICE
Category: Logistics, Information Technology, App Development, Healthcare Contract Logistics - QA, Information Solutions, Professional
Requisition Number: 064539