Hiring for Immediate Need for Business Analyst (validation) in Chennai, for Exp. 2 - 5 yrs at ValGen (Chennai Job)
(Not Shown) (Please mention IndiaDynamics.com when contacting)
Job Description:Responsible for the Testing, Implementation Support of the Validation System. Demonstrate expertise in at least one aspect of system qualification and regulatory compliance (e.g., EMEA, GCP, GLP, GMP, QSR, ERES) and internal requirements employing regulatory guidance and industry standards. & nbsp Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule.& nbsp Solid understanding in process cleaning validation and application of GMP with emphasis on the application of Change Control practices 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. Lead system qualification efforts and be the primary client contact for coordinating work, reporting status, resolving issues, and addressing change orders as they apply. Qualifications BE/BSc (Chemical Engg, Biotech Engg, Pharmaceutical Engg, Food Processing, etc.).& nbsp 2 - 5 years in Process / Cleaning / Analytical Method / Computer System validation experience. Experience in Pharma / Life Sciences (API / Formulations) Manufacturing Process. Experience in Project execution within at least one area of systems validation e.g., laboratory equipment, facilities utilities, manufacturing equipment, metrology equipment, information systems Ability to understand execute protocols including complex systems such as process validation, computer controlled systems validation, complex utilities and manufacturing equipment such as computer controlled filling systems, formulation systems and basis knowledge of laboratory validation. Must have strong attention to detail. Must have strong technical writing skills. Proficient in Microsoft Word, Excel, Power Point and Project. Ability to plan and manage own work. Ability to interact with clients in professional manner. Fluent in English, spoken and written. Willing to travel regionally and nationally throughout the India.