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2161 - Sr. Business Analyst - IT Compliance and Infrastructure Qualification

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Date: Jan 10, 2021

Location: Hyderabad, TG, IN Hyderabad, TG, IN Hyderabad, TG, IN Hyderabad, TG, IN

Company: Cytel Inc

Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services.  At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development.

 

 

The Sr. Business Analyst will work closely with our IT infrastructure and Quality Assurance (QA) teams to support our GxP Quality standards, regulatory requirements, and IT operational procedures and controls.

 

Cytel uses a risk-based approach to ensure IT Infrastructure meets standards and regulatory requirements including an internally hosted, managed infrastructure, as well as external infrastructures such as SaaS and PaaS.  Review & validation is done using the US FDA guidelines GxP and GDPs as well as internal organizational SOPs, work instructions & controls.  Ensured by internal audits, 3rd party audits, staff training, and operational controls.

 

This position will also drive the creation of change control, deviation, and CAPA records as needed to fulfill the compliance goals.

 

Qualifications:

  • Bachelor degree in an Information Technology field
  • 5 years experience with statistical software such as SaaS &/or PaaS.
  • Experience with QA oversight of IT documentation in an FDA environment (preferably clinical setting)

 

Why Cytel? 

  • Our collaborative working environment encourages innovation and rewards results, and we are proud to have one of the lowest turnover rates in the industry. 

  • In addition to competitive compensation, we offer an excellent benefit's package, annual bonus incentive, promote work-life balance, and the opportunity to grow with us! 

  • Work with respected experts and thought leaders 

Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytel’s human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.


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