DescriptionPurpose: Maintains the quality system continuous improvement program through the implementation and maintenance of quality standards and regulatory requirements.\r \rResponsibilities:\r \r\rDevelops, implements and maintains the division quality principles, systems and controls through the review of departmental documentation including training manuals and standard operating procedures (SOPs) and provides expert commentary on the completeness and adequacy of support for applicable regulatory requirements specific to system compliance under federal guidelines. \rMaintains the internal audit program which shall include establishing and maintaining audit standards per regulatory and company requirements. \rCoordinates and hosts customer (client, regulatory, etc.) audits as required. \rEnsures all inspection and review findings are followed up to completion. \rApprises senior staff of audit findings as necessary and initiates discussion with appropriate personnel to resolve issues. \rAssembles and maintains department quality reports for management review (Field Event Reports, Internal Incident Reports, Audit Reports, etc.), to include track and trend data analysis. \rProvides analysis of processes to other operational units on a periodic basis. \rCreates, revises, reviews and approves SOPs for department and other areas as applicable. \rReviews and approves validation protocols. \rUnderstands and interprets regulatory requirements and guidelines to ensure company compliance, and to maintain certification with regulatory authorities. \rParticipates and / or facilitates continuous quality improvement initiatives / teams. \rAssist in training new analysts and staff in quality system requirements and applicable regulations.
\rBachelor's degree with a minimum of 3 years experience in a quality assurance, specifically in clinical research or computer systems validation position. \rA strong working knowledge of GxP regulations, guidelines, and industry standards as they apply to computer systems used within the Life Sciences and Pharma industry. \rA solid foundation of knowledge in Quality Assurance and Quality Management principles. \rAn understanding of computer system validation practices as they apply to the Life Sciences and Pharma industry. \rAn understanding of the Pharmaceutical Research and Development Process. \rEffective organizational and analytical skills. \rAbility to work independently and in a team environment. \rIntermediate computer skills. \rBasic mathematical / statistical skills. \rEEO Minorities/Females/Protected Veterans/Disabled\r
Website : https://www.iqvia.com/
Healthcare is an industry designed to help humans. As a global community, we continuously invest and commit to advancing human health. To deliver value and real outcomes. To rise to the challenge to find the next breakthrough by making the most of increasingly limited resources. We are inspired by the potential and propelled by the possibilities. We share the vision to drive healthcare forward. To see how we can help accelerate progress and achievements. Others are developing these medical breakthroughs. We do our part by using breakthroughs in insights, technology and human intelligence to reimagine and deliver ways to help make them a reality. It’s bigger than better clinical trials. Or advances in technologies and analytics. Or faster insights. It’s about exploring a new path to better health outcomes via Human Data Science. It’s about harnessing the power of the IQVIA CORE™ to channel the insights, commercial and scientific depth, and executional expertise that drive maximum value for our customers. Motivated by the industry we help, we’re committed to providing solutions that enable life sciences companies to innovate with confidence, maximize opportunities, and, ultimately, drive human health outcomes forward.