Site Regulatory Compliance Internship

6 mesi fa

Guidonia Montecelio, Italia Merck KGaA A tempo pieno

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you’ve got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

**Your role**:
As an intern in Site Regulatory Compliance, you will gain valuable experience and contribute to ensuring regulatory compliance at Guidonia Site. Your role will involve supporting the Regulatory Compliance team in various tasks related to regulatory standards, quality management systems, and adherence to applicable Quality Standards. Moreover, you will gain valuable expertise in the administration and management of the TrackWise software system which is a widely used electronic quality management system (eQMS) that helps organizations manage various quality processes, including deviations, investigations, corrective actions/preventive actions (CAPA), audits, and change controls. In this aspect your primary responsibility is to ensure quality standards and regulatory compliance during the change control process within the Site Quality organization.

You may be involved in as an intern in Site Regulatory Compliance: support in the organization and maintenance of regulatory documents, including regulatory submissions, licenses, permits, and certificates. Ensure document change control processes are followed, as applicable; support the preparation, review and submission of regulatory documentation to relevant Health Authorities. Ensure accurate and timely completion of required documentation, adhering to regulatory deadlines agreed with CMC Teams and/or Global Regulatory Affairs; collaborate with the Site Quality team to identify opportunities for process improvement in areas such as documentation management, compliance tracking, and reporting. Help implement best practices and suggestions for more efficient and effective compliance processes; serve as the primary point of contact for the administration of the TrackWise system. Set up user accounts, manage role-based permissions, and maintain system configurations according to business requirements and standard operating procedures; implement change control procedures in alignment with organizational policies and regulatory requirements and ensure the correct TW workflow of the change controls. Coordinate and facilitate the change control process across departments or teams.
You will be able to collaborate with various departments such as Site Quality Assurance units, QC, Analytical & Pharmaceutical Development, API Operations, etc. to ensure alignment and consistent compliance throughout the organization.

**Who you are**:

- Degree/Post Degree in a relevant field such as Regulatory Affairs, Life Sciences, Pharmacy, or a related discipline
- Basic understanding of regulatory compliance principles and practices
- Familiarity with regulatory guidelines and standards relevant to the industry (e.g., FDA, EMA, ISO)
- Strong attention to detail and organizational skills
- Good analytical and problem-solving abilities
- Effective written and verbal communication skills (English is an asset)
- Proficiency in using Microsoft Office tools (Word, Excel, PowerPoint, Teams etc.)

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

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