Maria Pitler

Maria Pitler, New Jersey, USA

QUALITY ASSURANCE

Areas of Expertise 
Quality Control, Quality Assurance, Regulatory and Medical Writing. Experience across all therapeutic areas. Since 1990

Over 30 years of GLP and GCP QA/QC quality review and audit experience in the pharmaceutical industry to reduce risk, maintain high standards and produce high quality documents/deliverables for nonclinical (GLP) and clinical (GCP), clinical operations, medical writing, regulatory affairs and regulatory operations, pharmacovigilance, publication and promotional use, and global regulatory submissions. Assists in writing or writes QC SOPs, work instructions and QC checklists, implements and supports quality processes/system audits and provides quality control oversight of CRO deliverables (documents/data) for use by the sponsor for risk reduction and sponsor due diligence. Proactive GCP/GLP project team member and consultant for documents, data, and regulatory submissions. Helps to develop QC metrics and performs publication QC review of bookmarks and hyperlinks for accuracy. Provides QC training and education.Specialties: Quality Control reviews of nonclincal and clinical documents and data, QA/QC auditing of nonclinical and clinical, medical writing, publication, promotional review, regulatory submission documents and data, CTD modules. QC SOP and work instruction creation, oversight of CRO documents for quality and use by the sponsor, GCP veterinary pharmaceutical auditor of data and regulatory documents.Competent, Seasoned, Professional, Proactive, Ethical, Diplomatic, Compliant, and Personable Auditor

  • Leadership
  • Organizational and planning
  • Communication
  • Statistical analysis
  • Problem-solving
  • Industry-specific technical knowledge

Hourly Rate $90 USD

Please contact

9737043422

pitlerm@yahoo.com 

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