21 set - Como
Jazz Pharmaceuticals
Overview
As a Scientist Quality Control, you ensure analytical QC testing aligns with GMP and approved procedures within Gentium Srl. You play a key role in sampling, data integrity, and validation activities to support a robust QC program. You collaborate across the QA and production teams to sustain quality, safety, and compliance. This role offers impact at the intersection of science and patient care, within a global biopharma context.
Retribuzione / Benefits
total compensation packages
discretionary annual cash premio or incentive compensation
discretionary equity grants
market-competitive pay
career development opportunities
Responsabilità
Perform analytical QC testing per written instructions and training plan
Sample finished products, APIs, intermediates, starting materials, raw materials, packaging components, in-process control and cleaning validation samples per approved instructions
Apply QC and site procedures; report deviations to line manager/QA
Review analytical results and ensure data accuracy, traceability and integrity
Maintain lab and equipment cleanliness and qualification per instructions with safety and quality focus
Ensure reagents and standards are available, non-expired, and properly recorded in systems
Confirm correct labeling and storage of reagents, standards and samples
Participate in analytical validation, cleaning validation, and stability studies protocols/reports
Assist in quality deviation investigations as required
Draft QC lab instructions (SOPs, method validation protocols/reports, equipment qualification)
Engage in Continuous Improvements via Operational Excellence culture
Monitor compliance with GMP and Quality System within area of responsibility
Follow EH&S; procedures under the Integrated Management System
Attend training on Integrated Management System, GMP Quality, Procedures and protocols
Perform work in accordance with Legislative Decree ***** and company policies
Support compliance with Jazz Pharmacovigilance policy
Requisiti fondamentali
Knowledge of compendial requirements (USP-NF, Ph. Eur., ICH)
Experience in a Pharmaceutical QC laboratory
Experience with analytical method validation (protocol, execution, report)
Experience with qualification/maintenance of HPLC, UPLC, TOC, automated titrators
Experience with QC software: Empower 3 CDS, Chromeleon, LabX, TiAMO, OpenLab
Experience sampling/testing cleaning validation/verification, APIs, raw materials
Drafting/reviewing SOPs and technical documents in Italian and English
Good level of English (written and spoken)
Team-based and cross-project collaboration
Experience in 6S within QC laboratory
Education in chemistry related fields
Team building
capability of working in teams and on multiple projects
proactive in reporting deviations
HPLC
UPLC
TOC
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