Utrecht, Utrecht, Netherlands
Life sciences professional with 5 years of experience in the industry, specializing in quality and compliance-driven roles. My background includes ensuring GxP compliance, quality systems managing deviations, and performing quality control analyses using specialised techniques.With a strong foundation in quality systems, process integrity, and regulatory compliance, I bring a detail-oriented and proactive approach to safeguarding product and process quality.
-Batch record review of manufacturing and packaging records of imported medicinal products as per MA’s and EU GMP’s -Review of all associated reports to BMR, BPR, CoAs, deviations, OOS, OOT reports -Review of all documents of transport conditions associated to batch transportation -management of deviations
-Batch record review-both in paper and electronic record format- manufacturing, environmental monitoring and quality control data for in process and finished products with the use of ERP, EBR and LIMS -Ensured that labelling packages were complete and accurate -Prepared batch documentation for QA disposition and QP releasee
-Registered and maintained accurate clinical trial records on ClinicalTrials.gov & EudraCT, ensuring regulatory compliance. -Collaborated with clinical and regulatory teams to ensure clinical trial data met accuracy standards. -Submitted trials for results reporting and escalated compliance issues to ensure quality standards. -Coordinated with cross-functional teams(medical writers, programming, clinical teams, quality) to verify data accuracy and streamline workflows.
Key responsibilities: • Performed QA review of batch record release documents to support QP with batch release process and archive batch documentation. • On-site quality support for operational activities (including labelling and packaging). • Monitored sterile manufacturing areas (Grade A) • Identified and documented quality incidents and non-conformances , reviewed quality related documentation (WI, operational procedures), initiated investigations in case of Out Of Specification analytical results. • Prepared documentation and contributed to internal audits and health authorities inspections. • Initiated CAPAs, supported change controls, and supported improvement QA projects, maintained metrics for key quality parameters
Key responsibilities: • Performed quality testing over clean water (grade A areas) in a GMP-regulated setting. • Performed analytical testing on raw materials, in-process, finished product, and stability testing • Reviewed and approved laboratory tests results • Operated specialized scientific equipment such as HPLC, GC, UV, Titrator, TOC, IR. • Wrote and reviewed laboratory TMs, SOPs, and WIs as directed by company policy • Ensured that testing and results approval were completed within agreed turnaround times • Handled non-conformances/deviations in an accurate and timely manner. • Supported the use of Empower 3 software, LIMS and Microsoft Dynamics 365 • Maintained monthly metrics tracking key quality parameters • Followed GMP/GLP, FDA 21 CFR Part 11 guidelines, ICHQ10 principles and aseptic manufacturing processes.
-Assisted QC analysts with daily analyses on raw materials with the use of Karl-Fisher, Titrator, UV, IR, TOC, and Dissolution. -Calibrated daily weight balances and PH meter for maintenance -Sorted and organized materials such as physical files, tracking spreadsheets, and reports. -Organized company files to decrease workload and increase productivity