About this role
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 www.jazzpharmaceuticals.com for more information.
Job Description Brief Description: Perform Quality Control activities in compliance with GMP and approved procedure covering the role of Scientist Quality Control in the Quality Control laboratories in Gentium Srl (Villa Guardia). Primary Responsibilities: Perform analytical quality control testing according to written instructions and executed and approved training plan. Perform and support sampling of finished products, APIs, intermediates, starting material, raw materials, packaging components, in-process control and cleaning validation/verification samples according to approved instructions.
Apply the procedures governing the QC and the site. Promptly report to the line manager or QA any departure from standard processes and procedures, including out of specification test results. Review analytical results.
Is responsible for the accuracy, traceability and integrity of the data generated during the execution of the test and procedures he/she has performed and contemporaneous data recording. Keep the premises of the lab and relevant equipment in good status of cleaning and qualification according to approved instructions with specific reference to safety and quality aspects. Make sure that equipment used for testing and stability of products are qualified according to approved procedures and perform qualification of equipment.
Make sure that reagents and standards required for the execution of the analysis are available and within their expiry date including contemporaneous recording of information into the computerized systems. Make sure that reagents, standards and samples are always clearly labelled and correctly stored according to approved procedure. Participate in the preparation of analytical validation and cleaning validation protocols and reports and stability studies protocols and reports.
Participate in the investigation of quality deviation as required. Write, as applicable, QC lab instructions including but not limited to: SOPs, analytical method validation protocols/reports, equipment qualification protocols/reports, reference standard characterization, sampling instructions, stability protocol/report. Embrace the Continuous Improvements mindset by leveraging the Operational Excellence Culture and Tools in the day-to-day activities.
For her/his Area of relevance/responsibility monitor and ensure compliance with the GMP and Quality System. 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.
Perform all work activities, in compliance with the safety directives, as required by Legislative Decree 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: Knowledge of compendial requirements (USP-NF, Ph. Eur., ICH guidelines). Good experience in a Pharmaceutical Quality Control laboratory.
Experience in the execution of analytical method validation (protocol, execution, report). Experience with qualification and maintenance of HPLC, UPLC, TOC, automatic titrators, major laboratory equipment. Acquired/available experience for the use of the following QC analytical software: Empower 3 CDS, Chromeleon, LabX, TiAMO, OpenLab.
Experienced for sampling/testing Cleaning Validation/Verification samples, APIs, raw materials. Drafting and reviewing SOPs and technical documents both in Italian and in English Good level of English written and spoken. Team building and capability of working in teams and on multiple projects.
Experience in 6S within QC laboratory. Required/Preferred Education and Licenses: Degree in chemistry, CTF, biotechnology, biology Jazz Pharmaceuticals is committed to fair and equitable compensation. We provide total compensation packages that are market competitive.
For this role, the salary range is: €34,400.00 - €51,600.00 This range will be reviewed on a regular basis. Within this range, individual compensation will align to your qualifications, skills, relevant experience, job knowledge, and any other factors pertinent to the role. We ensure fair and competitive compensation aligned with your expertise and contributions, within our established pay framework and our Total Compensation philosophy.
Internal equity considerations will also influence individual base pay decisions. At Jazz, base pay is only one part of total compensation. You may also be eligible for a discretionary annual cash bonus or incentive compensation (role dependent), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.