CSV Specialist

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields. Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions! To support the installation of several manufacturing solid dosage equipment such as but not limited to: - Encapsulator - Checkweigher - Compression machine - Hardness tester - Encapsulation machine - Auxiliary equipmentMain activities should include: - Verification of the equipment installed and configured at the vendor site (FAT). - Implement the progression from FAT through IOQ in accordance with the CC strategy. - Installation at the manufacturing room for qualification activities. - Qualification activities in the manufacturing room areas. - Development of Standard Operating Procedures. - Generation and routing of calibration and preventive maintenance forms. - Development and approval of GxP and automation impact assessments. - Provide alternatives to resolve documentation situations. - Establish project communication and documentation controls. - Assure consistent quality of activities that meets or exceeds the requirements. - Bachelor in Science or related field - 5 years of experience as CSV consultant in regulated industry. - Experience with MS Office applications (Word, Excel and MS Project) - Excellent technical writing skills. - Bilingual: English and Spanish, speaking and writing. Benefits What We Offer - Opportunities for learning, development, and professional growth. - A collaborative and supportive work environment. - The opportunity to work with industry-leading clients on impactful projects.Your information will be kept confidential according to EEO guidelines.