Main responsibilities and activities
In the QC Department we are looking for a brilliant profile reporting to the QC Manager with the following responsibilities and activities:
Use the StarLims in order to perform all the approval activities related to system management; in particular: tests approval, monographs approval, clients approval, stability protocols/studies approval, analytical sheets approval.
Use the TrackWise system in order to manage/approve the laboratory investigations/deviations.
Use the TrackWise system in order to manage/approve the CCM records.
Act as QC manager backup in TrackWise, Smarteam and LIMS systems.
Manages the practical activities of the department in order to ensure compliance with xGMPs, regulatory guidelines / Divisional Policy etc.
Collaborates with the department manager in the issuance of analytical control procedures following reclamation activities.
Supports the department manager during audits and inspections (internal and external).
Ensures compliance with safety regulations in the department.
Coordinate a group of supervisor and lab analysts:
Supports Supervisors and, if necessary, Laboratory Analysts, in laboratory investigations (LIR, OOS, complaints) and in the implementation of effective CAPAs.
Supports the Supervisors in planning the activities of the department.
If necessary, replaces the Supervisor in the review and approval of the analytical work.
Review and approve the laboratory activities necessary for its maintenance (eg, instrumental requalification, periodic checks, daily calibrations).
Represents the practical contact point for the other departments of the Site.
Collaborates in the organization of internal professional refresher courses.
In line with the policies of the Human Resources department, it ensures the motivation and development of employees, intervening with appropriate managerial actions where necessary.
Requirements
Education:
University degree in Chemistry, Pharmacy or CTF
Skills:
Ability to work cross-functionally
Familiar with Quality IT Systems
Experience in Inspection management
Languages:
English and Italian (level of proficiency)
Minimum Experience / Training required:
Minimum: 4 years work experience in Quality Control
