Alexa Tarus Email & Phone Number

Valencia, Es

Valencia, Valencian Community, Spain

• Perform process mapping of current regulatory affairs processes and gap analysis versus industry best practices• Propose a series of enhancements and design updated processes with agnostic approach towards chosen RIM system• Engage with clients during sales meetings, participate in RfP and proposal development for the consultancy offerings within the R&D department• Develop and/or review SoW aligned with client expectations

Bucharest, Romania

• Wrote fully referenced content for Academy of Managed Care Pharmacy (AMCP) dossiers and global value dossiers (GVD), based on published clinical, scientific and pharmacoeconomic literature• Conducted targeted literature reviews to provide strategic insights on burden of illness, epidemiology, treatment landscape, unmet needs or other topics• Provided consulting services for the maintenance and continuous improvement of Quality Management Systems • Advised on compliance topics, including gap analysis, SOP authoring and/or reviewing • Auditor for compliance audits to EU and US regulations

Bucharest, Bucharest, Romania

Learning Spanish - level B1

Bucharest, Romania

• Obtained license for import, distribution and service of medical devices from relevant Competent Authorities in Romania (Medical Device Competent Authority and Nuclear Competent Authority)• Implemented Quality Management System in newly setup direct organization and obtained ISO Certification after successful outcome of internal and external Audit.• Certified ISO 9001 and 13485 Lead Auditor, performed Internal Audits and acted as SME in Audit preparation for local organization• Periodically track QMS related KPIs and submit Customer feedback to ensure compliance for the Region• Effective Post Market Surveillance, by ensuring timely submissions for Medical Device Safety Vigilance reports• Maintain communication and offer continuous support to local distributors, internal and external stakeholders• Coordinate and ensure nuclear product approvals, submissions and notification, as per local country requirement; track status of progress and maintain product database up to date• Execute communication package localization and liaise with business units to ensure implementation• Track product recalls for Mandatory field change orders (FCOs) to closure, inform Competent Authority and business units upon completion• Represent Philips in country government and regulatory agencies (medical device, environmental, nuclear)• Perform QMS relevant and Lean Basics training• Continuous improvement of process effectiveness, by using Lean tools (Problem Solving, 5S, Kaizen, Daily Management, VOC)

Bucharest, Romania

• Ensured compliance with applicable European, National regulations and relevant Regulatory Standards• Reduced the gap on local language labeling and supported the implementation of Romanian requirements by successfully creating and reviewing over 600 labels of medical devices• Ensured regulatory clearance of medical devices and biocides, updated and maintained the license for distribution of medical devices• Ensured proper maintenance of product documentation and local Regulatory document database• Prepared timely documentation and submitted product notification to Competent Authority• Gathered, evaluated, organized and managed information in a variety of formats• Coordinated copy review process for promotional materials• Responsible for in-country review of local language labeling• Ensured compliance with environmental regulation (e.g. WEEE, B&A, waste packaging, REACH)• Submitted periodical reports and acted as single point of contact to Environmental Authorities• Offered support in tenders with required documentation

Bucharest, Romania

• Handled technical customer queries and product investigations• Gained good knowledge of GDP requirements• Collected and compiled statistical quality data• Reviewed quality documentation including validation protocols and reports, change controls and GDP / GMP deviations• Reviewed the implementation and efficiency of Quality and inspection Systems• Observed and complied with company Standard Operating Procedures

Bucharest, Romania

• Learned Lean& Six Sigma tools and applied them in cost optimization projects• Project and contract management• Improved technical abilities by actively participating in cross-functional projects (Internal Control Framework, Stock Management)• Improved time management by prioritizing and coordinating resources and activities• Gathered and analyzed data in order to develop monthly EHS Scorecards with specific KPIs• Recorded and kept track of all activities at departmental level (RAID)• Gathered necessary skills to understand, develop and improve my profession inside a pharmaceutical company

Master'S Degree, Pharmacy

Bachelor Of Applied Science (Basc), Life Science, Bilingual