DUTIES RESPONSIBILITITES: To assure that the manufacturing operations Parenteral and/ or Oral Solid Dosage are performed in compliance with domestic and international cGMP regulations, and company policies and procedures. To provide scientific approach and Quality assurance direction to the approval of the GMP documents such as batch records, protocols, procedures, qualification and validation reports. Enforce critical analytical thinking in the investigation management process specifically during root cause analysis, risk assessment evaluation and corrective and preventive actions determination to guarantee that gaps are properly addressed.
• Bachelor Degree in Science (Chemical, Engineering, Biology, Pharmacy or Microbiology).• Six (6) years of experience in Quality Assurance responsibilities in a pharmaceutical industry.
• Knowledge of manufacturing operations of Oral Solid Dosage and Parenteral Products Manufacturing.• Strong knowledge of relevant GMP, FDA, EU regulations and the ability to interpret and apply them for intended use. • Fully bilingual (Spanish/English) communication skills, both written and verbal.• Proficient knowledge of computer systems (Microsoft Office etc.) and applications like Trackwise and SAP.• Solid ability for analyzing data detecting deviations, inconsistencies and interpret sampling test results.• Proficient knowledge of problem solving and root cause analysis methodologies (i.e. Kepner Tregoe)• Willing to work irregular hours, rotative shifts, weekends and holidays when needed.
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