Experience

Camber Pharmaceuticals Inc

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality and Regulatory Affairs Manager

  • Jan 2016 - Present

  Attributions:• Company’s technical responsible;• Responsible for Quality Assurance, Regulatory Affairs, Quality Control and Pharmacovigilance departments;• Responsible for complete company technical setup and administration initial plan setup;• Responsible for EHS activities (Environment/Health/Safety)• Responsible for HVAC and Power equipment maintenance program;• Responsible for technical documentation review and product registration;• Quality control Physical-chemical, Oncology and Microbiology laboratory project (Drawing, design, procurement, installation and startup);• Sustainability initiatives;• Warehouse and office project (Drawing, design, procurement, installation and startup);• Fully implementation of quality management system – QMS;• Brand protection plan- INPI• Saving projects;• Pharmaceutical equivalence activities coordination;• Plan and establishment of technical departments routine;• Licenses and authorization clearance;• Forecast and budget preparation;• Project risk and GAP analysis;• Support on finance and account activities (payroll, balance sheet, international funds transfer, social contract, establishment of employees benefits, Capex/ Expenses control, expenses reports to India team)• ROI analysis;• Pipeline plan;• Team recruitment and selection;



Accord Healthcare

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality and Regulatory affairs Coordinator

  • May 2012 - Jan 2016

  Attributions:• Company’s technical responsible;• Coordination of Quality Assurance, Regulatory Affairs, Quality Control and Pharmacovigilance departments;• Establishment of pharmaceutical equivalence center - laboratory project (Drawing, design, procurement and installation) and QMS implementation;• Licenses and authorization clearance;• ISO 9001:2008 audit and implementation;• Responsible for HVAC and Power equipment maintenance program;• Dossier and technical documentation review;• Post registration activities;• Pharmaceutical equivalence and bioequivalence activities coordination;• GMP license/ Authorization renewal;• Preparation of KPI;• ANVISA meetings and query meeting attendance;• Post-commercialization client meeting (technical discussion);• Quality assurance routine coordination (CAPA, investigation, customer complaints, self-inspection, supplier qualification, change control, risk analysis, documentation control, recall, software/cleaning/ transport/HVAC validation, equipment qualification, receiving and inspection, training program, product release);• Pest control;• Coordination and evaluation of analytical method validation;• Quality control routine coordination (Physical-chemical, Onco and Microbiology Lab: Finished product complete analysis, material procurement, calibration, equipment corrective and preventive maintenance, environment control);• Pharmacovigilance routine coordination (PSUR, information capture and trial, adverse event evaluation and investigation along with Intas team, AE information – CVS, mitigation risk plan and customer response);



Baxter International Inc.

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Receiving and inspection Jr. Analyst

  • Mar 2010 - May 2012

  • Chemical and non-chemical sampling;• Non-chemical analysis;• FT-NIR implementation and identification analysis;• Supplier qualification management (auditor qualification, supplier in loco audit, annual supplier evaluation, quality agreements and documentation control);• Quality KPI support;• Self-inspection auditor;• Customer complaint (receipt, address, evaluation, investigation, customer response and closure). • Chemical and non-chemical sampling;• Non-chemical analysis;• FT-NIR implementation and identification analysis;• Supplier qualification management (auditor qualification, supplier in loco audit, annual supplier evaluation, quality agreements and documentation control);• Quality KPI support;• Self-inspection auditor;• Customer complaint (receipt, address, evaluation, investigation, customer response and closure).