Hi I would like to submit your candidature for this position. Could you please tell me, How comfortable you are with this position.
*Role : VALIDATION LEAD * *Location : Menlo Park, CA. * *Duration : 6 months* *VALIDATION LEAD SUMMARY* Responsible for performing Computer System validation activities, including writing protocols and reports and compiling data and attachments into comprehensive validation packages. Also responsible for assisting with the development of procedures, specifications, validation master plans and other validation and engineering related documentation. *JOB RESPONSIBILITIES * · Responsible for supporting software validation in a GMP facility. · Develop Validation assessment and create Requirement Specification for software · Interface with Cross functional organization andthe ability to defend rationale in validation documents. · Author moderately complex validation tests and execute automated and manual scripts for IQ, OQ and PQ testing or supplemental qualification Understand and comply with all established corporate, IT, and software engineering policies and procedures. · Develop WIs and training manuals for in-house developed software · Prepare validation documents: functional requirements, change control, standard operating procedures (SOPs), and Requirement Traceability matrix. · Solve problems during validation process and address/advise on issues such as deficiencies, deviations and change control etc. · Execute validation work according to protocol instructions and procedures. · Compile validation packages and assure all required documentation is complete *MINIMUM REQUIREMENTS * · Experience in authoring, reviewing executing and approving validation documents · Degree in Electrical Engineering, Computer Science or related field and have a minimum of 5 years of experience in pharmaceutical/bio- tech/medical device industry · Working knowledge of regulations and guidances including cGMP – FDA 21CFR Part 11, Annex 11, Good Automated Manufacturing Practice (GAMP5), GLP and Good Automated Laboratory Practice (GALP) · Familiar with current industry practices in hardware/software validation and computerized systems such as Empower, COTS · Must be self-motivated and able to work with limited supervision · Ability to communicate effectively (written and verbal) and conduct effective meetings Thanks & Regards, Tarun Kumar | Sr Technical Recruiter| Pro-Tek Consulting | [email protected] | Contact number 213-259-8253 New Thinking. New Staffing. http://www.pro-tekconsulting.com -- You received this message because you are subscribed to the Google Groups "American Vendor--IT Consulting" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at https://groups.google.com/group/sap-vendor. For more options, visit https://groups.google.com/d/optout.
