| validation engineer local to NYC and NJ or MA at NYC, New York, USA |
| Email: [email protected] |
| Validation Engineer Contract C2C/w2/1099 Location: New York and New Jersey. ONSITE ROLE. Local to NYC and NJ only and MA Only USC GC GCEAD H4EAD OPTEAD Job description/details: NEEDS: NEED to be focused on data integrity. NEED Excellent Communication skills. MUST be Local to NY/NJ OR MA. NEED DL, VISA, Last four SSN, An active LinkedIn with a profile picture. Responsibilities: Develop and execute CSV plans and protocols for a variety of computerized systems used in Good Manufacturing Practice (GMP) environments, including Laboratory Information Management Systems (LIMS), Manufacturing Execution Systems (MES), Electronic Batch Records (eBR), and other relevant software. Maintain a strong focus on data integrity throughout the CSV lifecycle, ensuring compliance with FDA 21 CFR Part 11 and other relevant data integrity regulations (e.g., EU Annex 11). Conduct risk assessments for computerized systems, identifying potential data integrity vulnerabilities and recommending mitigation strategies. Participate in the development and implementation of data governance policies and procedures. Perform gap analyses to identify areas for improvement in our CSV processes and data integrity practices. Collaborate with cross-functional teams (QA, IT, R&D, Manufacturing) to ensure effective CSV and data integrity implementation. Prepare and maintain comprehensive CSV documentation, including validation protocols, test scripts, and traceability matrices. Support internal and external audits and inspections related to CSV and data integrity. Stay up-to-date on the latest regulatory requirements, industry best practices, and technological advancements in CSV and data integrity. Qualifications: Bachelor's degree in Computer Science, Information Technology, Pharmaceutical Sciences, or a related field. Minimum of 3-5 years of experience in CSV within the pharmaceutical industry. Strong understanding of GxP regulations (GMP, GLP) and data integrity principles. In-depth knowledge of FDA 21 CFR Part 11 and other relevant data integrity regulations. Proven ability to develop, execute, and document CSV protocols. Excellent analytical skills and a meticulous attention to detail. Strong communication, interpersonal, and teamwork skills. Proficiency in Microsoft Office Suite and familiarity with CSV software tools a plus. Kind Regards, Syeda Hajra | Absolute IT | Senior Technical Recruiter 116 Village Blvd Suite 200 Princeton New Jersey 08540 Absolute IT [email protected] https://www.linkedin.com/in/syeda-hajra-a96813245/ www.absoluting.com -- Keywords: quality analyst rlang information technology green card wtwo Massachusetts New Jersey New York validation engineer local to NYC and NJ or MA [email protected] |
| [email protected] View all |
| Wed Jul 24 18:54:00 UTC 2024 |