Company
QualityControlSupervisor
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Quality Control Supervisor. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement. Ensure that Quality Control processes for materials acceptance, batches, quality control and QC equipment validation/qualification are executed and fully compliant to cGMPs regulation, corporate and national guidelines.. Be the Deputy of QC Head in managing, coordinating and approving the execution of the analytical ”
Industry & Context.
Problem Solving Skills; In case of analytical results out of specification (OOS), out of trend (OOT), out of expectation (OOE) or System Suitability Test failures, and in case of deviations, in collaboration with QC Head, perform the investigation and verity the implementation of the related
Ensures high level of attention for handling of radioactive materials within the area of responsibility.
What They're Looking For.
Must Have
Scientific degree (preferred degree in Chemistry or equivalent), experience in Quality Control department, Open and clear collaboration and communication to make sure the daily operation runs smoothly, Shows the appropriate sense of urgency around given tasks, Reliable, present and able to transmit the energy necessary to continue an improvement process and consolidate the system, Languages: Italian fluent, good knowledge of English, written and spoken
What You'll Do.
Ensure that Quality Control processes for materials acceptance
quality control and QC equipment validation/qualification are executed and fully compliant to cGMPs regulation
corporate and national guidelines.
Be the Deputy of QC Head in managing
coordinating and approving the execution of the analytical activities for the batch release and in raw materials and packaging materials acceptance.
review and approve the records of the QC activities (i. e. logbook
analytical batch record).
Ensure that the stock of materials
standards is properly available and ensure that all QC materials are properly and safely stored
labelled recorded and monitored according to SOPs and ensure the correct storage of Reference and Retention Samples of the raw materials.
In case of analytical results out of specification (OOS)
out of expectation (OOE) or System Suitability Test failures
and in case of deviations
in collaboration with QC Head
perform the investigation and verity the implementation of the related.
Ensure that all methods used in QC analysis are validated according to SOPs
MA and support the QC Head to assure the adequacy of the SOPs of Quality Control redaction and review of SOPs
Collaborate with QC Head for the redaction of the stability programs and the annual product ensure that the stability analysis are performed on.
Collaborate with QC Head to ensure the initial and periodic training of QC manage the presence
shifts and performances of the QC Technicians when QC Head is not on.
Collaborate with QC Head for the periodical self-inspections and external audits (Health Authorities
Supplier); contribute in maintaining the local quality system as per GMPs and corporate guidelines and in assuring the respect of the GMPs and Health Authorities requirements at local.
Support the development and implementation of projects related to new or existing products.
Guarantee the cleanliness and tidiness and application of Good Laboratory Practice.
Ensures high level of attention for handling of radioactive materials within the area of responsibility.
Running operations in full compliance with HSE guidelines (internal/external).
How You'll Work.
Team & Collaboration
Open and clear collaboration and communication to make sure the daily operation runs smoothly; Collaborate with QC Head for the redaction of the stability programs and the annual product ensure that the stability analysis are performed on; Collaborate with QC Head to ensure the initial and periodic training of QC manage the presence, shifts and performances of the QC Technicians when QC Head is not on; Collaborate with QC Head for the periodical self-inspections and external audits (Health Authorities, Certified Bodies, Supplier); contribute in maintaining the local quality system as per GMPs and corporate guidelines and in assuring the respect of the GMPs and Health Authorities requirements at local
Communication Scope
Open and clear collaboration and communication to make sure the daily operation runs smoothly; good knowledge of English, written and spoken
Full Job Description
**Job Description Summary** The QC Supervisor supports the QC Head to ensure that Quality Control processes for materials acceptance, batches, quality control and QC equipment validation/qualification are executed and fully compliant to cGMPs regulation, corporate and national guidelines. **Job Description** **Major Accountabilities:** * Be the Deputy of QC Head in managing, coordinating and approving the execution of the analytical activities for the batch release and in raw materials and packaging materials acceptance according to the specifications; * Maintain, review and approve the records of the QC activities (i.e. logbook, form, analytical batch record); * Ensure that the stock of materials, reagents, standards is properly available and ordered; ensure that all QC materials are properly and safely stored, identified, labelled recorded and monitored according to SOPs and specifications; ensure the correct storage of Reference and Retention Samples of the raw materials and products; * In case of analytical results out of specification (OOS), out of trend (OOT), out of expectation (OOE) or System Suitability Test failures, and in case of deviations, in collaboration with QC Head, perform the investigation and verity the implementation of the related CAPAs; ensure that all methods used in QC analysis are validated according to SOPs, MA and cGMPs; support the QC Head to assure the adequacy of the SOPs of Quality Control department; redaction and review of SOPs, Protocols and Reports; * Collaborate with QC Head for the redaction of the stability programs and the annual product review; ensure that the stability analysis are performed on time; * Collaborate with QC Head to ensure the initial and periodic training of QC analysts; manage the presence, shifts and performances of the QC Technicians when QC Head is not on site; * Collaborate with QC Head for the periodical self-inspections and external audits (Health Authorities, Certified Bodies, Supplier); contribute in
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