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Sr. Gxp Trainer

Sr. Gxp Trainer

Posted by EmploymentCrossing
Posting ads for 9 years
Location: Branchburg, NJ

Responsibilities: IES Every effort has been made to identify the essential functions of this position. However, it in no way states or implies that these are the only duties you will be required to perform, nor is it intended to be such a listing of the skills and abilities required to do the job. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or is an essential function of the position. 1. Develop and deliver GXP and Quality System Training for internal personnel. 2. Develop/deliver training programs to address CAPAs, as needed. 3. Ensure Trainer Qualification is achieved and maintained for internal GXP Trainers. 4. Review and disseminate pertinent GXP related literature and relevant FDA activities to OLAD and the GXP cross functional groups, as applicable. 5. Develop/deliver New Hire Orientation, GXP, and Quality System Training Programs. 6. Develop eLearning Courses for GXP and Quality Systems and develop other ELearning initiatives, as required. 7. Provide consultation to internal client groups regarding training issues associated with nonconformance events and audits. 8. Work closely with internal client groups to provide relevant GXP and group specific technical training opportunities via Webinars, Teleconferences, and seminars. 9. Ensure Training Effectiveness by developing appropriate Training Assessments. 10. Develop and implement new OLAD training initiatives, as required. 11. Manage/supervise projects and/or project teams, as requested. 12. Serve as a resource for establishing core GXP training requirements. 13. Attend GXP/Quality System Training Programs as required. Requirements: BA/BS degree in the sciences or relevant Technical discipline 2. Minimum 35 years (710 years, Senior) experience in the Pharmaceutical/Biotech industry including experience providing training on GXPs and Quality Systems. 3. Must possess a thorough knowledge of GXP regulations and other regulations as applicable. 4. Must have experience managing projects, managing project teams and/or supervising staff. 5. Must be capable of working independently with minimum direct supervision. 6. Biotech/Pharmaceutical manufacturing, laboratory, and/or QA experience is required. 7. Strong understanding of all Quality functions and business areas is required. 8. Excellent written and oral communication skills are required. Must be computer literate. 9. Must have strong computer skills, including MS Word, PowerPoint and Excel. Experience with Project Management and eLearning is desirable.Travel Requirements:NoneEmployment Type:FullTime

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