Remy Arce Email & Phone Number

Windermere, FL, US

Home Office: Windermere, FL, USA

Translations that take your intended message to your target audience in an accurate and user-friendly manner:*translation, and localization of medical informed consent forms (ICF) for clinical trials* medical questionnaires* marketing products* operational manuals* websites terms of use and privacy policies* world reach programs through the internet*.

Orlando, FL

-Review and redesign of Standard Operating Procedures to comply with Remediation Plan under an FDA Consent Decree environment.-Auditing of documentation for compliance with Regulatory Standards.

Subcontracted as a Corporate Quality Auditor. Audited completion and implementation of site Remediation Action Plans (under FDA Consent Decree) for the areas of Documentation, Manufacturing Systems, Batch Records Systems, Warehouse Operations, Pest Control Program, etc. Translated and verified translation of documents from English to Spanish as part of the.

Subcontracted to work in the site Remediation Plans (under FDA Consent Decree) to meet all documentation standards. Involved in the writing and translation of Standard Operating Procedures and the simplification of GMP documentation as well as in the preparation of the corresponding Evidence Binders to Corporate and FDA officersof the remediation plans for.

Execution of Consent Decree's Remediation Plans for Central Documentation Department.

Managed and executed projects that covered the Assessment, the Auditing for GMP Compliance, the Translation of GMP documents (English/Spanish), the Simplification and Redesign of documents, and the Develop/Review of Standard Operating Procedures. My assignments covered the following companies:Bristol Myers-Squibb (USA, Puerto Rico, Ortho-McNeil, PSGA.

Managed all plant Quality Assurance and Control Systems. Involved in the proofreading of translated documents to assure quality of translation for the intended audience. Prepared training materials and presentations in both, English and Spanish.