Gmp Support Bardi

Gmp Support
Bardi
Emilia Romagna, Bardi

GMP Support

**-

**234207

**OUR COMPANY

At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals.

Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective.

Now, we are powered by 52, 000 employees globally who nurture a diverse, collaborative and inclusive culture.

We believe that if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve.

**THE POSITION

In this position you will join the GMP Compliance team in our production site in Fornovo San Giovanni (BG) and report directly to the Manager.

You will be responsible of activities related to GMP compliance in Quality Control and act as a Manager Backup Laboratory Instrumentation management and GMP topics.

**Tasks & responsibilities

- Ensuring continuous update of SOPs according to Local/Corporate guidelines and applicable regulations;

- Performing and/or evaluating equipment performance verification, focusing on metrological holistic aspects, drafting SOP and Working Instructions, revising supplier protocols, reports, procedures and services operators trainings;

- Providing training, documentation and support necessary to ensure GMP compliance;

- Coordinating and evaluating equipment maintenance ordinary/corrective activities and providing reports about completion and release for use;

- Supporting GMP compliance manager in internal and external audit;

- Acting as validation manager for instrument and/or software validation;

- managing Events, Deviation, CAPA and change control in Trackwise system;

**Requirements**:

- Bachelor's Degree in Science (Chemistry or Information Technologies, or engineering);

- 4/5 years of experience in Quality Control Lab (Pharma companies), Consulting companies for Validation topics, Analytical instrumentation companies;

- Must be familiar with the regulatory requirements of the EU-GMP for active pharmaceutical ingredients, ISO 9001, guidelines on data integrity (e. g WHO, PICs, FDA);

- Languages: Native level of Italian language and fluent English level (B2/C1);

- Strong knowledge of Office package;

- Accountability, agility, proactivity, teamwork orientation.

**WHY BOEHRINGER INGELHEIM?

- With us, you can grow, collaborate, innovate and improve lives. _

We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices.

In addition, learning and development for all employees is key, because your growth is our growth.

To learn more about what benefits could be waiting for you, please visit our Career area

**Job

- Quality/Compliance

**Primary Location

- Europe-IT-Lombardia-Fornovo San Giovanni

**Organization

- IT-Bidachem (Italy)

**Schedule

- Full-time