**Job Details**: - Req ID: - R010494
- Location: - Villa Guardia, Como, IT
- Category: - Technical Operations **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.
- 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.
- 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.
- Technical writing skills including protocols, reports, SOPs.
- Ability to work independently and as part of a team. **Required/Preferred Education and Licenses**
- Required: Experience working in a quality assurance role at a pharmaceutical manufacturing site.
- Required**:Fluent**I**talian 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.
- Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law._

📌 Quality Assurance Specialist (Villa guardia)
🏢 Jazz Pharmaceuticals
📍 Villa guardia