Quality Assurance Specialist

Samsic HR; Villa Guardia; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A global biopharmaceutical corporation in Lombardia, Italy is seeking a Quality Assurance professional to contribute to the maintenance and improvement of their Quality System. The role involves conducting investigations, overseeing compliance with SOPs, and ensuring the quality standards in manufacturing processes. Candidates must have a Bachelor's degree in life sciences, experience in a quality assurance role, and fluency in both Italian and English. Benefits include medical insurance and retirement savings plans.

Servizi

Medical insurance

Dental and vision insurance

Flexible paid vacation

Retirement savings plan

Competenze

• Experience in quality assurance role at pharmaceutical manufacturing site.
• Fluent in Italian and English.
• Authorization to operate as a QP is a plus.

Mansioni

• Conduct investigations for deviations and root-cause analysis.
• Oversee Quality System and ensure compliance with SOPs.
• Write and review GMP documents and technical reports.
• Conduct self-inspections and support audits.
• Embrace Continuous Improvements with Operational Excellence.

Conoscenze

Quality Management System

Technical writing skills

Team collaboration

Regulatory compliance understanding

Independence in work

Formazione

Bachelor's or higher degree in a life sciences subject

Descrizione del lavoro

If you are a current Jazz employee please apply via the Internal Career site.

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life‑changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient‑focused and science‑driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information.

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

• Conduct investigations in case of deviations and appoint required personnel for effective root‑cause analysis and definition of suitable corrective/preventive actions.
• Define and verify Corrective / Preventive Actions following investigations.
• Verify the application of the Company Quality System (e.g. SOPs, Quality Agreements) by both GMP related relevant departments and external personnel.
• Ensure complaints from customers and to suppliers are recorded and managed according to Company’s SOP and appoint required personnel for effective root‑cause analysis and definition of suitable corrective/preventive actions.
• Interact and work with internal departments at site for management of change and deviation investigations.
• Interact with the CMO regarding manufacturing, changes, deviations and release activities of the Drug Product.
• Write and review SOPs, technical reports and other GMP documents in compliance with applicable standards.
• Perform a complete review of batch production records verifying accuracy, completeness and presence of relevant attachments in compliance with relevant SOPs.
• Before manufacturing a new batch, issue the related batch record and packaging batch record according to relevant SOP.
• Guarantee traceability and proper management of relevant documents of the quality system with specific reference to: Batch Records, CoAs, Training Records, Failure/change control records, and other relevant GMP documents.
• Evaluate changes for his/her area of competence and perform relevant actions for change implementation.
• Organize and conduct self‑inspections to affected departments, support during audit/inspection by clients/Regulatory Authorities.
• Perform periodic review in production (QAIP) according to relevant SOP.
• Write Product Quality Review documents.
• Embrace Continuous Improvements mindset by leveraging Operational Excellence Culture and Tools in day‑to‑day activities.
• Follow Environmental, Health and Safety procedures in compliance with company policy; apply relevant guidance and indications of Integrated Management System.
• Attend education and training courses in Integrated Management System, GMP, Quality, Procedures, Instructions, manuals, and Operational Protocols.
• Oversee work and ensure implementation of directives received, checking correct performance of workers, and exert functional initiative as provided by legislative Decree nr. 81/08.
• Ensure compliance with all applicable laws, codes, corporate standards and procedures related to area of relevance/responsibility, including legislative decree 231/2001 and requirements of Jazz Pharmaceuticals Code of Conduct.
• Strict observance and knowledge of Jazz Pharmacovigilance 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 Directive 2001/83/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.”

Equal Opportunity Statement

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.

Benefits

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings, please contact HR.