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