Please reply to nar...@sriveninfosys.com

Title:                 LEAD Validation Analyst (Must have LEAD Exp.) 

Duration:           3 months

Location:           Waukegan, IL

 

Phone Interview

 

Description:-

 

Pharmacovigilance or adverse event knowledge and experience helpful. This is a 
team lead position that can do all the documents, not just testing. They will 
be in charge of the validation of the project and reporting to a PM. They are 
in charge of lifecycle deliverables. There are 2 small projects that will be 
managed and must be able to multitask to keep projects on time with 
deliverables.

 

5 + YEARS OF EXPERIENCE

Minimum 2 years experience with validated systems within a regulated industry.

 

 

RESPONSIBILITIES: 

Lead/support validation efforts and deliverables for projects requiring 
validation. Create and execute validation test scripts and document test 
results in accordance with standards. Review and evaluate validation 
assessments for application systems/projects. Review/revise Validation Policy 
and SOPs as directed. File validation documentation within following Quality 
Assurance Library guidelines

 

COMPETENCIES: 

Outstanding verbal and written communication skills, Customer Service Focused; 

Information Technology background, experience within a Quality/Regulated 
environment; 

System Audit /Validation background/experience; excellent organizational and 
project management skills including SDLC. 

 

QUALIFICATIONS: Associate Degree minimum or equivalent combination of education 
and work experience. Minimum 2 years experience with validated systems within a 
regulated industry. Experience writing Standard Operating Procedures and 
validation policies. Advanced knowledge and understanding of IT concepts and 
word processing and spreadsheet skills. Laboratory, product, and manufacturing 
knowledge/experience are a plus.

 

OTHER: Primary responsibilities will include leading the validation effort for 
the project including providing validation guidance to the project team and 
validation effort plans to the Project Manager. Other activities include 
writing and reviewing validation documentation and obtaining approvals. 

 

Candidate must have experience working in a validated environment with a GxP 
background in the pharmaceutical industry. 

 

Soft skills needed to succeed in this environment: team player, project 
management skills and excellent writing and communication skills. Other skills 
include quick study in learning a system, analytical background, result 
oriented and good at meeting deadlines.

 

Thanks & Regards
Naresh 
Technical Recruiter
Sriven Infosys INC
Voice: 212-999-6251 Ext: 217
Alt: 646-644-2894
Fax: 212-658-9460
nar...@sriveninfosys.com 
www.sriveninfosys.com

Sriven Infosys Inc is an Equal Opportunity Employer. Qualified applicants will 
receive consideration for employment without regard to race, color, religion, 
sex, national origin, ancestry, citizenship, disability, age, military or 
veteran status, and other characteristics.
We help our clients, employees & partners compete and win!

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