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Job Overview:

Join global organization with 82000+ employees around the world, as a IT Compliance based in IQVIA Bangalore .You will be part of IQVIA’s world class technology team and will be involved in design, development, enhanced software programs or cloud applications or proprietary products.

Role Overview:

Senior Analyst, IT Compliance role will collaborate with internal regulatory, business, and IT product teams, as well as other stakeholders, to ensure compliant delivery of AI/ML solutions within IQVIA’s RDS IT. This role will provide guidance to RDS IT’s product, system validation, operation teams on GxP compliance, implementation, and risk-based validation processes, regulations, and assist in monitoring CAPAs.

Principal Accountabilities:

•            Follow IT system lifecycle (SLC) processes and guide teams to enable the implementation and delivery of compliant  AI/ML solutions.

•            Guide teams on the risk assessment process and application of security controls to the GxP solutions and monitor risk profiles on an ongoing basis. Consult and advise other teams on all matters related to computer system validation.

•            Assist managers and other senior staff in authoring SOPs, work instructions, or templates as part of the continuous improvement plan.

•            Adhere to the Quality Management System and collaborate with internal teams to identify and devise plans to mitigate process and regulatory gaps.

•            Review validation artifacts, software inventory records, including monitoring of periodic quality review completions to maintain a validated state.

•            Ensure the GxP,  AI/ML solutions is compliant with regulatory requirements such as 21 CFR Part 11 or Annex 11, etc.

•            Collaborate with the immediate manager to convey any changes in compliance requirements or operating procedures to the team.

•            Partner with the team members to develop internal training and presentations on SLC and other process-related materials.

•            Partner with senior members of the team to provide support during customer audits and internal Quality Assurance audits.

•            Work with the product teams to address corrective and preventative actions resulting from audit/inspection findings or other quality events pertaining to solutions.

Essential Functions:

•            4+ years’ experience in healthcare, life sciences (Pharma, CROs), related product or service industry.

•            2+ years’ experience in implementing GxP regulated IT systems with focus on strong technology orientation.

•            Current knowledge of industry trends and best practices- for progressive quality risk management in a regulated environment including SQA functions, software testing, and test automation,  AI/ML model testing.

•            Understanding of the fundamentals of GxP regulations, validations for  AI/ML solutions, software development processes and procedures, including agile approach.

•            Experience with ISO and other standards bodies and international standards, FDA regulatory requirements (21 CFR part 11, GxP, etc.)

•            Understanding of regulatory implementations across cloud-based platforms and deployments such as Salesforce, AWS, or Azure, etc.

•            High-level understanding of technology, data science and/or machine learning concepts, with the ability to convey to non-technical audiences.

•            Workflow analysis and regulatory documentation.

•            Must have good people skills and the ability to interact and communicate effectively, orally and in writing, across all levels.

•            Ability to work well in both a team and individually. Excellent writing, organizational and problem-solving skills.

•            Strong client service orientation. Good communication skills, including the ability to liaise with people across the business.

•            Ability to prioritize and work on tight deadlines and at the same time focus on Quality.

Qualifications

•            Minimum Bachelor’s degree in Computer Sciences, Life Sciences, Information Systems, or relevant field.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com