Senior Consultant-Computer System Validation-Life Sciences

Senior Consultant- Computer System Validation- Life Sciences

We are looking for smart, self-driven, high-energy people with intellectual curiosity and passion for excellence; specifically, we are looking for candidates at Senior Consultants levels who are experienced in IT Computerized System Validation (CSV) within Life Sciences domain.

Responsibilities:

• Create, review, and approve validation deliverables

• Define IT system development processes (build, test, deploy, monitor) following Agile ways of working and ensure followed compliance in each release /Iteration

• Working experience on Agile/JIRA, Confluence, ALM

• Author major project validation deliverables as per client's standard operating procedures

• Review and approve system lifecycle deliverables generated by project team

• Guide project teams on applicable validation, security, and project management deliverables

• Advise project team on implementation of compliance and security control requirements at the appropriate stages of system development

• Contribute to internal and external audits, assessments, or inspections

• Escalate critical compliance findings, risks, or issues into appropriate client units

• Prepare management reports regarding compliance operations and progress

Basic Skills & Experience

text-indent:-.5in;mso-list:l2 level1 lfo1"> • 5 plus years of professional experience in the Life Sciences industry working for a consulting services organization and/or industry.

auto;text-indent:-.5in;mso-list:l2 level1 lfo1"> • Good understanding of key pharmaceutical compliance regulations like 21 CFR Part 11, GxP and GAMP 5.

auto;text-indent:-.5in;mso-list:l2 level1 lfo1"> • Experience creating, reviewing and approving validation deliverables.

auto;text-indent:-.5in;mso-list:l2 level1 lfo1"> • Knowledge of risk management processes.

auto;text-indent:-.5in;mso-list:l2 level1 lfo1"> • Thorough knowledge in compliance and validation concepts.

auto;text-indent:-.5in;mso-list:l2 level1 lfo1"> • Proven ability in supporting multiple projects, responding quickly to changing situations in complex environments.

auto;text-indent:-.5in;mso-list:l2 level1 lfo1"> • Preferable IT background to understand complexities on the program.

auto;text-indent:-.5in;mso-list:l2 level1 lfo1"> • Collaborative attitude.

auto;text-indent:-.5in;mso-list:l2 level1 lfo1"> • Location: New York, New Jersey, Indianapolis

text-indent:-.5in;mso-list:l2 level1 lfo1"> • Candidates authorized to work for any employer in US without employer-based visa sponsorship are welcome to apply. Infosys is unable to provide immigration sponsorship for this role at this time

Required Skills & Experience

text-indent:-.5in;mso-list:l2 level1 lfo1"> • Strong understanding of pharmaceutical compliance regulations and validation concepts.

auto;text-indent:-.5in;mso-list:l2 level1 lfo1"> • Experience with Agile and Waterfall methodologies.

auto;text-indent:-.5in;mso-list:l2 level1 lfo1"> • Familiarity with tools like ServiceNow, JIRA, Veeva, HPALM.

auto;text-indent:-.5in;mso-list:l2 level1 lfo1"> • Ability to manage multiple projects and adapt to complex environments.

auto;text-indent:-.5in;mso-list:l2 level1 lfo1"> • IT background preferred to understand program complexities.

text-indent:-.5in;mso-list:l2 level1 lfo1"> • Excellent communication and collaboration skills.

For candidates based out of NY,NJ states, estimated annual compensation will be $130000 to $17700

Along with competitive pay, as a full-time Infosys employee you are also eligible for the following benefits :-

• Medical/Dental/Vision/Life Insurance

• Long-term/Short-term Disability

• Health and Dependent Care Reimbursement Accounts

• Insurance (Accident, Critical Illness, Hospital Indemnity, Legal)

• 401(k) plan and contributions dependent on salary level

• Paid holidays plus Paid Time Off