Site Regolatory Compliance And Audit Specialist Lazio

Site Regolatory Compliance And Audit Specialist
Roma
Lazio, Lazio

When you're part of Thermo Fisher Scientific, you'll do challenging work, and be part of a team that values performance, quality and innovation.

As part of a successful, growing global organization you will be encouraged to perform at your best.

With revenues of more than $24 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

**Location/Division Specific Information

The pharmaceutical manufacturing plant in Ferentino (80km from Rome), with more than 850 employees, is specialized in commercial contract manufacturing of injectable drugs, both liquid and lyophilized formulations, with an increasing focus on biologics.

**How will you make an impact?

We are looking for a highly motivated, result-driven professional, who is willing to take up an all-round role in an international environment and will actively contribute to the success of critical projects for the Ferentino Site.

**What will you do?

- AIFA NOTIFICATION: notification to AIFA for essential and not essential changes of the site;

- Application of import permit for blood derivatives, request of MIA extension based on current regulations

- Guarantee the regulatory compliance of API, excipients, primary pck, GMP materials and Elaborate Risk assessment for the regulatory compliance of excipients, collecting and filing in a database all the certifications needed for pre-clinical/1/2/3/commercial products

- Cooperate with the team to assure compliance of the company procedures to current regulations (legislations, guidelines as GMP, FDA, etc. )

to compliance of Corporate policies

- Perform internal audit and cooperate for client's audit to assure compliance of the company procedures to current regulations (legislations, guidelines as GMP, FDA, etc.

)

- Issue of the Capa plan coming from internal audits and management of the relative CAPAs in accordance to procedures and company quality standards;

- manage supplier qualification by questionnaire

- Ensure and work for the correct execution of Regulatory and Clients audits through the provision of necessary information and documentation.

**How will you get here?

Scientific/pharmaceutical degree (FCT, Pharmacy, Chemistry, Biotecnology, Chemical Engineering)

- Knowledge of current regulatory requirements

- Knowledge of GMP, pharmaceutical legislation and national and international guidelines

- Knowledge of Regulatory Audit and supplier Audit

- At least 2 years of previous experience in similar role

**Knowledge, Skills, Abilities

- Communication skills

- Commercial orientation

- Ability to manage data and statistical analysis

- Fluent in Italian and English