The opportunity
Directly responsible for post marketing activities of PIs formerly produced in Bulciago site.
Maintaining business processes and/or subsystems focused on achieving predefined Quality standards and enhancing overall performance.
Keeping updated policies, processes, documented information.
Implementing and maintaining key Quality management goals.
How you’ll spend your day
MAIN ACTIVITIES AND RESPONSIBILITIES:
Responsible for the post marketing activities of APIs formerly produced in Bulciago site:
• make sure that quality related complaints are investigated and resolved.
• perform product quality reviews and stability reports.
• ensure the managing of recall according to procedure and regulations.
• execute quality risk assessments if needed.
• manage returns according to company procedure and regulations.
• manage NMT (Notification to management) and QAM is needed and act in the escalation process through completion and closure.
• manage dispatch of batches from the external warehouse.
• update QTAs if needed.
• collaborates with the Regulatory Affairs function to ensure conformity, completeness and correspondence of the regulatory documentation.
• act as quality interface with internal and external customers when dealing with activities such as QTAs, supplier qualification, issue resolution, complaints, product information, and customers’ specification.
• issue statements related to Bulciago products assuring total compliance to current GMP, GDP, Data lntegrity requirements.
Responsible for Compliance activities of Caronno and Villanterio sites:
• processing of documents through the generation, modification, review and approval workflow (SOPs, test methods, specifications, protocols, reports, etc.).
• tracking, trending and reporting of Quality Metrics to monitor site performance on them.
• review of regulatory and quality compliance requirements and Corporate Standards, performance of gap assessments, and establishment or improvement of SOPs covering all areas of applicability.
• development and monitoring of corrective action plans where needed.
• support to Regulatory Affairs for any updates/ changes to Regulatory Registrations (DMFs/CEPs).
• manage tracking of GMP type training supporting plant performance.
• definition of SOP and Skill matrix.
• review, approve and guarantee the execution on time of the CAPAs defined together with the involved departments in order to prevent reoccurrence or occurrence of events and anomalies detected during documentation review, investigation and/or quality monitoring during internal audits and walkarounds.
• implement remediation actions assigned as responsible of the relevant activities.
• support the Site Quality Head and the Qualified Person in the investigation of a notified complaint.
• issue complaint reports with SMEs cooperation.
• notify complaints to suppliers of materials and services highlighted during internal investigations.
• review the complaint reports provided by the notified suppliers of materials and services.
• support the Site Quality Head, the Qualified Person and the Quality Assurance in the investigations related to Compliance.
• issue investigation reports with SMEs’ cooperation.
• coordinate and support the investigations related to the department assigned and review and approve the deviation reports provided by the responsible departments.
• support identification of needs to license the site with the regulatory bodies.
• support the Site Quality Head collecting and verifying the information to include in the notifications.
• perform internal audits; participate in regulatory authority and other external compliance audits.
• support Inspections Readiness Plan execution.
• establishment and review of QTA with customers.
• support drafting and maintenance of a Site Master File.
