Senior Quality AssurancePrimary 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.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.
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