Hi Professionals,

Please let me know if you have any resource for this position.



Keywords :  Validation Lead, IQ, OQ, PQ, Life Sciences, ELN





*Job Title*

Validation Lead

*Relevant Experience *

*(in Yrs)*

7+

*Technical/Functional Skills*

·         7 to 10 minimum years of experience in the Pharmaceutical
industry.

·         Excellent verbal and written communication skills, Customer
Service Focused; Information Technology background, experience within a
Quality/Regulated environment including SDLC.

·         Strong interpersonal and technical writing skills and the ability
to interact across divisional boundaries.

·         Ability to manage multiple tasks and projects simultaneously, and
to prioritize work, goals and tasks per the divisional and corporate
objectives.

·         Ability to report results clearly and concisely. Sound reasoning
and ability to quickly analyze and solve complex problems.

·         Significant Work Activities & Conditions Continuous sitting for
prolonged periods (more than 2 consecutive hours in an 8 hour day)

·

·         Associate Degree minimum or equivalent combination of education
in science and work experience.

*Experience Required*



*Roles & Responsibilities*

·         Lead/support validation efforts and deliverables for systems used
for Discovery/Development Sciences/Instruments/Clinical/Pre-clinical with
minimal oversight.

Develop the validation testing strategy for large and medium sized projects
and develop the overall Validation plans and timetables.

·         Review and Trace validation test scripts and documented test
results, in accordance with company standards, to verify full test
coverage, based on VRB Approved Validation Strategy, and acceptable
results.

·         Review and evaluate validation assessments for application
systems/projects.

Ensures that validation project documentation is in compliance with company
policies and procedures

·         Prior Experience with validation of Discovery/Development
Sciences/instruments/Clinical systems preferred.

Require prior experience in creating Change Requests, Developing Validation
Plan, test scripts, Summary Reports, Traceability Matrix and other
validation project documents in the Pharmaceutical industry

·         File validation documentation within Quality Assurance Library
guidelines.

Ensures that project documentation is in compliance with AbbVie’s policies
and procedures

·         Provide regular status reports on of validation activities in the
organization to Validation SME, PM and/or Validation or IT Manager, as
requested.

*Generic Managerial Skills*



*Education*

Associate Degree minimum or equivalent combination of education in science
and work experience

*Start date* (dd-mmm-yy)

1-Jun-2015

*Duration of assignment *(in Months)

12 months

*Work Location *

Waukegan, IL









Thanks & Regards,

*Raj Yadav*

Email: rya...@sysmind.com

Ph: 609-897-9670 x 2168

Fax: 609-228-5522

SysMind LLC

Address: 38 Washington Road, Princeton Jn, NJ 08550



*[image: cid:image001.gif@01CD1E36.E1381A30]* <http://www.sysmind.com/>

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