Scientist Quality Control

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7z47v1

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 81/08 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

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7z47v1