PLEASE SUBMIT ONLY RESUMES, WITH CONTACT INFORMATION, CURRENT LOCATION, AND
RATE CONFIRMATION TO AVOID FURTHER DELAY IN SUBMISSION.

LEAD Validation Analyst * (must have LEAD experience)*
3 months
Phone Interview
Waukegan, IL
Rate: $45/hr all inclusive

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 deliverable. There are 2 small projects that
will be managed and must be able to multitask to keep projects on time with
deliverable.


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.


Sareen Bhaskaran
Resource Manager
Prosoft Cyberworld Group
630-371-0530 ext 145
[email protected]
YAHOO IM:  sareen_prosoftcyberworld

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