Senior Compliance Analyst
Cognizant Technology Solutions
Bydgoszcz, Poland
Published 2 weeks ago
Compliance Management Systems / Technology
Are you a highly experienced Compliance Analyst with a deep understanding of Computer System Validation (CSV) within the Life Sciences industry? Do you thrive in ensuring IT systems meet the highest regulatory standards across diverse environments? Join our team and play a pivotal role in maintaining the integrity and compliance of our critical systems.
We are seeking a proactive and meticulous Senior Compliance Analyst with a strong background in Computer System Validation (CSV) in accordance with FDA, EMEA, and ISO guidelines. The ideal candidate will possess extensive expertise in validating IT systems within the Life Sciences industry, encompassing infrastructure and application compliance across various environments, including On-Premise, Cloud, and Mobile solutions. A profound understanding of regulatory frameworks such as GAMP, GxP, and risk-based validation is paramount for this role.
Key Responsibilities:
If you are looking for another opportunity and are interested in the company, do not hesitate to apply online!
Stay up to date with our recent events - follow us on LinkedIn or Facebook .
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.
#LIAZ1
The Cognizant community:
We are a high caliber team who appreciate and support one another. Our people uphold an energetic, collaborative and inclusive workplace where everyone can thrive.
Cognizant is one of the world's leading professional services companies, transforming clients' business, operating, and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build, and run more innovative and efficient businesses. Headquartered in the U.S., Cognizant (a member of the NASDAQ-100 and one of Forbes World's Best Employers 2024) is consistently listed among the most admired companies in the world. Learn how Cognizant helps clients lead with digital at www.cognizant.com
Cognizant is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.
Disclaimer:
Compensation information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.
Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.
We are seeking a proactive and meticulous Senior Compliance Analyst with a strong background in Computer System Validation (CSV) in accordance with FDA, EMEA, and ISO guidelines. The ideal candidate will possess extensive expertise in validating IT systems within the Life Sciences industry, encompassing infrastructure and application compliance across various environments, including On-Premise, Cloud, and Mobile solutions. A profound understanding of regulatory frameworks such as GAMP, GxP, and risk-based validation is paramount for this role.
Key Responsibilities:
- Lead and execute comprehensive Computer System Validation (CSV) activities, ensuring strict compliance with FDA, EMEA, ISO, and GxP standards.
- Validate critical IT software systems, including Quality Management Systems (QMS), within highly regulated environments.
- Provide expert oversight and strategic consultation on IT infrastructure compliance, including cloud-based systems, Commercial Off-The-Shelf (COTS) solutions, and server migrations.
- Develop, implement, and maintain robust CSV strategies and validation plans for new system deployments and significant changes.
- Ensure all systems are deployed and meticulously maintained in a validated state throughout their entire lifecycle, adhering to SDLC (Software Development Life Cycle) and IT Change Control processes.
- Author, review, and maintain Standard Operating Procedures (SOPs) specifically related to infrastructure and migration compliance.
- Prepare and execute comprehensive validation documentation, including Requirements Specifications, Validation Plans, Test Protocols (IQ/OQ), Installation Checklists, Test Summary Reports, Traceability Matrices, and Validation Reports.
- Provide expert guidance on the implementation of Risk and Compliance modules, ensuring alignment with relevant regulatory and infrastructure standards.
- Manage and maintain all CSV documentation diligently, ideally leveraging systems such as Veeva QualityDocs/QMS.
- Support tools qualification processes and conduct thorough documentation reviews to ensure compliance across diverse IT environments.
- Bachelor's or Master's degree in Life Sciences, Computer Science, Information Technology, or a closely related field.
- Several years of progressive experience in Computer System Validation (CSV) specifically within the Life Sciences industry.
- Demonstrable strong knowledge of GAMP 5, GxP, and contemporary risk-based validation approaches.
- Practical experience with Veeva systems, various cloud platforms, and navigating complex regulated IT environments.
- Exceptional documentation skills, coupled with excellent communication and proven stakeholder management abilities.
- Opportunity to be part of a rapidly expanding global organization
- Pleasant and inspiring working atmosphere
- Professional development and clear career path
- Training & development opportunities
- Private healthcare and additional life insurance (for permanent employees)
- Employee volunteering programs and opportunities
- Inclusion and diversity in practice
- Employee referral program in place
If you are looking for another opportunity and are interested in the company, do not hesitate to apply online!
Stay up to date with our recent events - follow us on LinkedIn or Facebook .
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.
#LIAZ1
The Cognizant community:
We are a high caliber team who appreciate and support one another. Our people uphold an energetic, collaborative and inclusive workplace where everyone can thrive.
- Cognizant is a global community with more than 300,000 associates around the world.
- We don't just dream of a better way - we make it happen.
- We take care of our people, clients, company, communities and climate by doing what's right.
- We foster an innovative environment where you can build the career path that's right for you.
Cognizant is one of the world's leading professional services companies, transforming clients' business, operating, and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build, and run more innovative and efficient businesses. Headquartered in the U.S., Cognizant (a member of the NASDAQ-100 and one of Forbes World's Best Employers 2024) is consistently listed among the most admired companies in the world. Learn how Cognizant helps clients lead with digital at www.cognizant.com
Cognizant is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.
Disclaimer:
Compensation information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.
Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.