Need LEAD Validation Analyst (QA)

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
sareen@prosoftcyberworld.com
YAHOO IM:  sareen_prosoftcyberworld

PLEASE MARK A CC TO recruitersareen@gmail.com