CHANGE CONTROL SPECIALIST

12 ago - Gallicano Nel Lazio
Gi Group SpA Filiale di Frosinone

FILIALE: FROSINONESPECIALIZZAZIONE: CORE SKILL - Life Science

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Grafton LifeScience* is a dedicated team focused on enhancing the experiences, skills, and potential of candidates in Sales & Marketing, Clinical Research, Regulatory, and Operations within the Pharmaceutical and Medical sectors. We also specialize in roles related to customer support in the health-impacting distribution field (Pharmacies and Parapharmacies).We are a team of passionate professionals working to guide our candidates towards roles and corporate environments that best match their skills and expectations.

In partnership with an integrated CDMO with around 60 locations worldwide, specializing in integrated sterile liquid and lyophilized product development and commercial manufacturing, we offer an opportunity for

Change Control Specialist




The main function of a Change Control Specialist is to ensure the effective management of the change control process within the Quality System, supporting readiness for manufacturing and batch release. This role ensures compliance with company procedures and regulatory standards, enabling timely production and release of pharmaceutical products.

Main Responsibilities:

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- Supervise the change control process with specific focus on production and batch release
- Follow the change control opening phase by verifying the proposed change and ensuring completeness of information and documentation
- Lead preliminary assessments of change proposals and identify potential impacts to guide the evaluation process
- Support the approval phase by verifying the presence and consistency of assessments and action plans for implementation
- Collaborate with relevant departments to ensure effective communication with customers and external agencies
- Participate in periodic meetings with customers, customer audits, and regulatory inspec

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