Senior Tech Compliance Analyst- Hyderabad (Hybrid)

Requirements

• Bachelor's Degree in Computer Science or related science field or equivalent.
• Experience with 21 CFR Part 11 required
• Experience in computer systems validation/software development life cycle approaches.
• E xperience in working in a clinical trials environment, including a comprehensive knowledge of GCP regulations guidelines
• Effective verbal and written communication
• Get to know Syneos Health
• Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and

Benefits

Additional Information

Senior Tech Compliance Analyst- Hyderabad (Hybrid) Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Every day we perform better because of how we work together, as one team, each the best at what we do. We bring together talented experts across a broad spectrum of business critical corporate functions. Every role plays an essential part in enabling our customers to achieve their goals. Our teams are agile, collaborative, and committed to delivering-for each other, for our customers, and ultimately for the people who rely on the services we support. Discover what your 25,000 future colleagues already know: Why Syneos Health - We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. - We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life. - We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities Job summary The IT Compliance Analyst supports the quality and compliance activities within the Information Technology (IT) department. The primary responsibilities will include managing IT's Computer System Validation (CSV) Programs to lead and oversee site validation activities ensuring compliance with internal company validation procedures and industry regulations for validation activities. The ideal candidate will have knowledge and experience in the area of Good Clinical Practices (GCPs) guidance and applicable clinical regulations, including FDA 21 CFR part 11, as related to developing, implementing, validating, maintaining and supporting assigned computerized systems in order to en s ure that operations are implemented and maintained in a compliant state. Job responsibilities - Manage and/or coordinate the writing and execution of validation protocols, specifications, change controls and/or scripts related to software, instruments and/or equipment according to the organization's compliance requirements and industry regulations. - Provide support for Information Technology's project portfolio within assigned projects, ensuring that technology solutions are classified in accordance with set standards, implemented to support those standards within agreed upon timelines. - Coordinate assigned project deliverables with external consultants and suppliers concerning the implementation, validation, support and maintenance to ensure these activities are completed in alignment with standard compliance principles. - Serve as subject matter expert in specialized project area to support client and regulatory agency audits and inspections for Information Technology activities. - Lead compliance efforts for any corrective or preventative actions plans supporting assigned Information Technology solutions. - Execute harmonization of compliance activities to support mergers, acquisitions and internal expansion of the compliance program. - Act as a compliance resource expert to other groups. - Assist internal clients with requests and problem resolution, participate in the maintenance of documentation and make recommendations for greater effectiveness in functional area of compliance - Make recommendations for continued improvement in the area of compliance for Information Technology. - Perform training in the principles of computerized systems validation for internal personnel. - Conduct periodic reviews of validation documentation to ensure systems continue to operate in a validated state, and perform impact assessments on planned GxP and Business Critical Change Management requests. - Perform quality reviews of validation deliverables.

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