Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting
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
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