Qc Chemical Analyst

patheon italia spa

📍 monza italy italy🕐 1mo ago🔗 workday

Job Description

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting **Job Description** **This role will:** * Ensure continuity of GMP release testing activities supporting manufacturing and batch disposition (e.g: HPLC, UV, Karl Fisher). * Ensure timely execution of stability testing in accordance with regulatory commitments and approved stability programs. * Maintain laboratory capacity to support strategic customers, including MSD and Novo Nordisk, avoiding delays in product release and customer deliveries. * Support compliance with GMP requirements, internal procedures and data integrity expectations. * Mitigate the risk of increased workload on the existing analytical team, preventing delays, overtime, reduced flexibility and potential quality risks. **Main activities carried out by the QC Analyst:** **Release Testing** * Execution of routine GMP analytical testing for commercial batch release. * Documentation of analytical activities according to GMP requirements. * Review of analytical data and completion of laboratory documentation. * Investigation support for laboratory deviations and atypical results. **Stability Testing** * Execution of stability analyses according to approved stability protocols. * Management of scheduled stability testing to ensure compliance with regulatory commitments. * Documentation and review of stability data **Other responsibilities** * Support laboratory investigations (Deviations, OOS, OOT and LIRs). * Support equipment qualification, calibration and routine maintenance activities. * Execution of method verification activities when required. * Support continuous improvement initiatives and laboratory compliance activities. * Collaboration with Production, QA and other QC functions to ensure timely product release. **Other requirements:** * Minimum 2 years of previous experience in relevant field. * Availability to work on the first shift (6:00–13:30) and second shift (13:15–20:45). * Preferred education: diploma in Chemistry, or Degree in Chemistry/Pharmacy/Ctf * Basic knowledge of English (A2 level); Fluency in Italian
Qc Chemical Analyst at patheon italia spa | MergeJobs