ISO 9001 Jobs in Puerto Rico

Experience (manufacturing process development or quality assurance) in Biotech or pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance problem solving critical thinking project management and quality systems. Proficient and experienced in ow...

SummaryThe Quality Applications Specialist supports quality systems and product transfer activities by ensuring compliant validation of computerized systems and manufacturing processes. The role focuses on sterilization equipment process validation and quality system compliance in regulated environm...

Responsible for providing quality leadership governance and expertise in Quality Assurance processes related to the manufacture. Ensure compliance with regulatory requirements and West procedures. Proactively develop lead and drive the execution of the Quality Assurance strategy. Develop and impleme...

Lead and execute Computer System Validation (CSV) activities for Quality Information Technology systems in compliance with FDA GxP ISO and global regulatory requirements.Conduct and maintain formal validation documentation including Validation Plans Risk Assessments IQ OQ PQ protocols and reports an...

Experience with: VeevaTrackwiseCAPAChange ControlRequirementsDoctorate degree OR Masters degree and 3 years of Manufacturing Operations experience ORBachelors degree and 5 years of Manufacturing Operations experience ORAssociates degree and 10 years of Manufacturing Operations experience ORHigh scho...

Experience in deviations DQMS experience in leading multidisciplinary teamsRequirements-Doctorate OR Masters 2 years of Manufacturing Operations experience OR Bachelors 4 years of Manufacturing Operations experience OR-Associates 8 years of Manufacturing Operations experience OR-High school/GED...

Experience with Veeva Trackwise CAPA Change ControlRequirementsDoctorate degree OR Masters degree and 3 years of Manufacturing Operations experience ORBachelors degree and 5 years of Manufacturing Operations experience ORAssociates degree and 10 years of Manufacturing Operations experience ORHigh sc...