Sara Markovic Email & Phone Number

Belgrade, Rs

Belgrade, Rs

Conducting external GxP audits of IT vendors and CROs (specialty labs) on behalf of clients, onsite and remotely, while serving as co-auditor and lead auditor. Authoring and reviewing audit reports, ensuring accurate documentation of findings, and providing actionable recommendations for quality improvements. Monitoring and ensuring the timely execution of all audit activities, maintaining adherence to defined timelines. Reviewing and providing inputs on Quality Management System (QMS) procedures and processes, aligning them with industry standards and regulatory requirements. Serving as key support during client qualifications, providing necessary documentation, and assisting in the completion of questionnaires. Participating in the internal validation of the regulatory system, ensuring compliance with industry standards and regulatory requirements. Possess broad knowledge and understanding of industry guidelines across various GxP areas, including FDA 21 CFR Part 11, Annex 11, ICH E6, Q9, Q10, and OECD GLP.

Ensuring strict adherence to relevant Good Manufacturing Practice (GMP) guidelines and regulatory authorities' approved files (eCTD) for products manufactured by third-party (Contract Manufacturing Organizations - CMOs). Conducting reviews, evaluations, and approvals of CMOs' manufacturing and testing documents to ensure compliance.Coordinating changes in manufacturing and testing processes of external production, working closely with supply chain, purchasing, and regulatory departments to maintain supply continuity and prevent out-of-stock situations due to regulatory noncompliance. Implemented a timely and proactive approach to ensure smooth operations; Processing changes in an electronic Quality Management System (eQMS).Establishing strong relationships with CMOs through effective communication, efficient organization, and active engagement in meetings and site visits. Resulted in reduced delays and escalations.Maintaining inspection-ready status and enhancing data integrity through proper document archiving and database updates. Practicing a structured and timely escalation process to senior management. Conducting technical reviews of deviations and risk assessments and actively engaging in discussions concerning quality deficiencies of medicinal products.Proactively managing new product launches by gathering essential documentation from CMOs, generating statements and actively participating in kick-off and follow-up meetings. Ensuring the accurate and up-to-date maintenance of the list of upcoming launches.Facilitating the onboarding process for new employees through the delivery of comprehensive training sessions.

Serbia

Efficiently managed the end-to-end process of handling product complaints, ensuring timely entry into the system, prompt dispatch of samples, thorough investigation, and comprehensive reporting.Tracked the qualification status of third-party partners, while also preparing drafts for Quality agreements to maintain effective collaborations.Produced engaging presentations and informative statistics graphs for the Annual Quality Review, providing insights into quality performance.Actively contributed to the development and maintenance of Standard Operating Procedures (SOPs), work instructions (WI), and other supporting documents. Performed final checks on technical elements to ensure accuracy.

Serbia

Belgrade, Serbia

Serbia