*Hiring Now .................. Please Reply ASAP with your consultant resume to kanahiy...@consultingknights.com <kanahiy...@consultingknights.com>*
*Job Title : Validation Lead with GMP/CSV Location : Menlo Park, CADuration : 6+Months ContractPhone and Face to Face InterviewNotes:* -will be joining a very small team, must be self directed (previous experience working autonomously) -strong, well-rounded validation skills -must have great documentation AND communication skills -must be local -10 years minimum CSV experience and must have recent projects working as a (hands on) lead *Responsibilities: * Computer System Validation processes expert. Maintain expertise in current and emerging GMP requirements and quality trends (e.g., 210, 211, 820, and 21 CFR Part 11). Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule. Lead system qualification effort and be the primary contact for coordinating work, reporting status, resolving issues, and addressing change orders as they apply. Demonstrate expertise in system qualification and regulatory compliance and internal requirements employing regulatory guidance and industry standards. Qualifications: Bachelor's degree in scientific or engineering discipline along with 10 plus years of experience in the field of computer validation and qualification. Previous experience working with higher level systems. Demonstrate expertise in system qualification (GAMP 5) and regulatory compliance and internal requirements employing regulatory guidance and industry standards. Must have excellent verbal communication and technical writing skills. Experience with all pertinent industry best practices (e.g., ISPE GAMP) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, Delta V, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report). Working knowledge of the development of protocols for the Validation of complex computer systems (e.g., multiple GAMP classes of systems) Protocol development will include ability to develop Installation, Operational and Performance qualification documents. Experience in Project execution within systems validation – quality systems Ability to plan and manage own work *Regards,Kanhaiya JaiswalProfessional RecruiterConsulting Knights Inc, Princeton, New Jersey |08540Phone : 609-423-4355 | Fax: (609) 228-5321kanahiy...@consultingknights.com <kanahiy...@consultingknights.com>www.consultingknights.com <http://www.consultingknights.com>* -- You received this message because you are subscribed to the Google Groups "it req" group. To unsubscribe from this group and stop receiving emails from it, send an email to it-req+unsubscr...@googlegroups.com. To post to this group, send email to it-req@googlegroups.com. Visit this group at https://groups.google.com/group/it-req. For more options, visit https://groups.google.com/d/optout.
