Eduard V. Email & Phone Number

• Diploma of Technology (Financial Management) - BCIT• Small Business Owner• M.Sc. Biochemistry- Simon Fraser University• 10+ years of QC/QA/Regulatory experience in the biopharmaceutical industry• Held key positions that supported IND, CTA and NDA submissions• Conducted GMP and GLP compliance Audits of CMOs and CROs• Responsible for updating and implementing additions to Quality and Documentation systems• Knowledgeable in GxPs and FDA and ICH regulatory requirements• Familiarity with ISOs 9000, 9001, 13485, and 14971• Experienced in effectively coordinating and managing multiple, full cycle projects simultaneously• Proven problem solver; analytical, strategic thinker• Excellent interpersonal communications; team focusedKEY SKILLS AND COMPETENCIES:• Critical thinker able to evaluate business concepts and with a strong belief in the impact of effective project management and Quality systems on business success• Effective communicator with the ability to see “the big picture” and encourage individuals to take responsibility for activities related to meeting required goals and objectives • Experienced with effectively working with cross-functional, multi disciplinary corporate teams. Organized team member(s) and maximized their ability to effectively prioritize and manage multiple projects simultaneously• Experienced in planning and implementing updates to QA systems to meet regulatory requirements• Detail oriented individual that endeavors to ensure accuracy in documentation and related processes• Experienced in technical writing and the evaluation of data from diverse analytical methods• Familiar with numerous equipment specific software packages and with issues related to validation of computer systems and laboratory instruments • Experienced with Microsoft Office suite, Project, Visio, and data analysis packagesSpecialties: Data Analysis

Listed skills include Auditing, Quality Management, Quality System Compliance, Planning, and 32 others.

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  Manager Of Quality And Operations

  Econotech Services Ltd

  Jan 2017 - Present - Delta, Bc, Canada