Brief Description:
Active contribution to maintenance and improvement of the Quality System at the Manufacturing site and overview of the CMO activities for Drug Product
Essential Functions/Responsibilities
* Conducts proper investigations in case of deviations and appoints the required personnel for an effective root-cause analysis and proper definition of suitable corrective/preventive actions.
* Defines and verifies Corrective / Preventive Actions following investigations.
* Verifies the application of the Company Quality System (eg. SOPs application, Quality Agreements) by both GMP related relevant departments and external personnel.
* Makes sure that complaints from customers and to suppliers are recorded and managed according to Company’s SOP and appoints the required personnel for an effective root-cause analysis and proper definition of suitable corrective/preventive actions.
* Interacts and work with internal department at site for management of change and deviation investigations
* Interacts with the CMO regarding manufacturing, change, deviations and release activities of the Drug Product.
* Writes and reviews SOPs, technical reports and other GMP documents in compliance with the applicable standards.
* Performs a complete review of the batch production records verifying its accuracy, completeness, and presence of relevant attachments in compliance with what prescribed by the relevant SOPs.
* Before the manufacturing of a new batch, issues the related batch record and packaging batch record according to what prescribed by relevant SOP.
* Guarantees traceability and proper management of the relevant document of the quality system with specific reference to: Batch Records, CoAs, Training Records, Failure/change control records, and other relevant GMP documents.
* Evaluates changes for his / her area of competence and performs relevant actions for the change implementation.
* Organizes and conduct self-inspections to affected departments, supports during audit/inspection from clients/Regulatory Authorities.
* Performs periodic review in production (QAIP) according to relevant SOP.
* Writes the Product Quality Review documents.
* Embrace the Continuous Improvements mindset by leveraging the Operational Excellence Culture and Tools in the day-to-day activities.
* Follow Environmental, Health and Safety procedures in compliance with the principle of the company Policy; apply the relevant guidance and indications of the Integrated Management System.
* Attend education and training courses in the Integrated Management System, GMP, Quality, Procedures, Instructions, manuals, and Operational Protocols.
* Oversee the work and ensure the implementation of directives received, checking the correct performance of workers, and exerting a functional power of initiative as provided by legislative Decree nr. 81/08.
* Ensure compliance with all applicable Laws, Codes, corporate standards, and Procedures related to her/his area of relevance/responsibility, included the legislative decree 231/2001 and requirements of the Jazz Pharmaceuticals Code of Conduct.
* Strictly observance and knowledge of Jazz Pharmacovigilance’s Policy.
Required Knowledge, Skills, and Abilities
* Quality Management System (Documentation, Training, Suppliers Qualification, Complaints, Deviations, CAPAs, Change Control, Audits.
* Understand and apply regulatory/guidance documents to ensure compliance.
* Technical writing skills including protocols, reports, SOPs.
* Ability to work independently and as part of a team.
Required/Preferred Education and Licenses
* Required: Bachelor's or higher degree level in a life sciences subject.
* Required: Experience working in a quality assurance role at a pharmaceutical manufacturing site.
* Required: Fluent Italian and English language skills
* Preferred: authorization to operate as a QP according to European Directive2001/83/EC and Italian "Decreto Legislativo n.219 April 2006, as amended, implementing EU Directive 2001/83/EC and Eudralex Vol. 4, Annex 16, as amended."
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