Site Conformance Specialist - Rosia, Italia - GSK

GSK

Azienda verificata

Rosia, Italia

2 settimane fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

Site Name:
Italy - Rosia

Posted Date:
Feb

Scopo dell'attivitå:

Acts as a liaison between Regulatory Affairs and Industrial Operation & Quality for new submissions, post approval change submissions, and any strategy discussions, to ensure that Regulatory submissions related to the site accurately reflect operations.

Acts as a liaison between Regulatory Affairs and Industrial Operation & Quality for change control, ensuring the preliminary regulatory evaluations (Regulatory Advice 1) of change requests

Acts as a liaison between Regulatory Affairs and Industrial Operation & Quality for managing the implementation of new project "Method of Analysis and Method of Production Improvement Process" Ensures proper oversight and data accuracy checks on documentation submitted in regulatory dossiers, variations and all official communications with Health Authorities.

Participates and support the Health Authorities Questions & Answers process.

Ensure oversight and traceability of post approval commitments

Descrizione dell'attivitå:
Ensure quality check revisions at document level review of new submissions, post approval change submissions and official communication to Health Authorities, this means:

Perform the review and approval of submission package, prepared by Global Regulatory Affairs, ensuring the accuracy, consistency, completeness and alignment of the information reported in submission documents versus the data provided in the related source document.

Ensure that the appropriate version of document is available as source for Regulatory submissions Verify that critical and non-critical parameters reported/modified within the source documents supporting the variation are aligned with that reported in the dossier

Ensure that appropriate Subject Matter Experts is identified as reviewer/approver of regulatory submission

Ensure proper management of identified gaps in both dossier sections and source documents.

Ensure tracking of the regulatory actions generated during submission process of the product:
Review/Approve answers to questions from Health Authorities impacting the site

Ensure timely implementation of post approval commitments taken by the site in response to questions received from Health Authorities.

Provide regular follow-up of post approval commitments taken by the site

Supports the evaluation of Change Requests in terms of regulatory compliance:

Actively participate to appropriate meetings.

Performs the preliminary regulatory evaluation (Regulatory Advice 1) of Change requests opened at Siena and Rosia sites o Identify Method of Analysis/Method of Production needed to support post approval change submissions and artici ate in their review/a roval rocess

Conoscenze professionali/ tecniche:

MSc or PhD in science field and/or experience in Pharmaceutical Industry.

Experience/technical familiarity with vaccines manufacturing and testing.

Quality mind-set with experience in quality assurance in a GMP regulated environment. Knowledge of cGMP regulations / ISO regulated environment.

Previous experience of Regulatory Compliance and Regulatory Affairs matters is desired.

good knowledge and expertise of regulatory processes related to the preparation and maintenance of registration dossiers and to the management of Questions & Answers and Post Approval Commitments.

In depth knowledge of EMEA, FDA, JP and other regulatory authorities' requirements.

Project management experience either in the scientific or business operation capacity is desired.

Experience of working in matrix environment.

Excellent communication (written and verbal) and organization skills.

Fluent use of English language (spoken, written).

Technical knowledge of manufacturing and quality activities related to biological products. Knowledge of Change Control system.

Interpersonal skills:

Good interpersonal, communication (including presentation) and influencing skills.

Excellent organizational skills, effective time management, ability to clearly identify priorities and manage multiple tasks

Ability to create and maintain networks and build relationships transversally across the GSK network. Creative approach to problem solving.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive.

Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people.

While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive.

We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclu