Hiring Now .................. Please Reply ASAP with your consultant resume to kanahiya.j@consultingknights.com
Job Title : Validation Lead with GMP/CSV
Location : Menlo Park, CA
Duration : 6+Months Contract
Phone and Face to Face Interview
Notes:
-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 Jaiswal
Professional Recruiter
Consulting Knights Inc, Princeton, New Jersey |08540
Phone : 609-423-4355 | Fax: (609) 228-5321
kanahiya.j@consultingknights.com
www.consultingknights.com
-- Job Title : Validation Lead with GMP/CSV
Location : Menlo Park, CA
Duration : 6+Months Contract
Phone and Face to Face Interview
Notes:
-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 Jaiswal
Professional Recruiter
Consulting Knights Inc, Princeton, New Jersey |08540
Phone : 609-423-4355 | Fax: (609) 228-5321
kanahiya.j@consultingknights.com
www.consultingknights.com
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