Site Regulatory Compliance Internship
Merck KGaA, Darmstadt, Germany
Guidonia
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Azienda: Merck KGaA, Darmstadt, Germany Guidonia
Esperienza: Esperienza in conformità normativa
Titolo di studio: Laurea/Post laurea in Affari Regolatori, Scienze della Vita, Farmacia o disciplina correlata
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 Track Wise 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 Track Wise 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, Power Point, Teams etc. )
✔ Merck KGaA, Darmstadt, Germany