Tech Compliance Analyst I

3074 Syneos Health d.o.o. Beograd; Hyderabad; Hybrid; INR 900,000 - 1,200,000; Full time

Job summary

Syneos Health in Hyderabad is seeking a Tech Compliance Analyst I to support validation activities for software, instruments, and equipment, ensuring adherence to 21 CFR Part 11 and GMP/GxP standards within the IT domain. You'll coordinate validation protocols, write specifications, and contribute to change controls and audit readiness.

You will collaborate with IT project teams, external consultants, and internal clients, providing compliance expertise, supporting audits, and promoting

Qualifications

• Bachelor's degree in Computer Science or related field or equivalent.
• Experience with 21 CFR Part 11 required
• Experience in computer systems validation / software development life cycle
• Experience in a clinical trials environment, including knowledge of GCP
• Effective verbal and written communication

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.

Skills

21 CFR Part 11

Computer systems validation

GCP regulations knowledge

Verbal and written communication

Education

Bachelor's Degree in Computer Science or related science field

Job description

Tech Compliance Analyst I

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®. Discover what our 29,000 employees, across 110 countries already know.

WORK HERE MATTERS EVERYWHERE

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 our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.

Job Responsibilities

Core 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.

Qualifications

• 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.
• Experience 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 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.

Learn more about Syneos Health. http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world.

Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.