- Role :Application Designer
- Role Description :Assist in defining requirements and designing applications to meet business process and application requirements.
- Must Have Skills :CSV (Computer System Validations)
- Good To Have Skills :No Technology Specialty
- Job Requirements :
- Key Responsibilities : a: Authoring and peer review of key validation documents as per Good Documentation Practices b: Perform and support compliance / validation activties c: Collaborate with and coach all teams to ensure client processes and validation goals are understood and followed/met
- Technical Experience : a Knowledge of Pharma Regulatory Compliance and CSV b Knowledge of GxP environment with experience in validation life cycle and V-Model c Good understanding of Good Documentation Practices d Undertsanding of V-Model, Waterfall model and Agile Methodology, Cloud-based environments and packages and tools such as SAP, HP ALM, ServiceNow etc
- Professional Attributes : a: Author and review key validation documents b: Develop, update and maintain internal documents c: Record and report compliance related measurement information for metrics reporting d Effective presentation and written skill e Positive attitude,leadership
- Educational Qualification : BE
- Additional Information : a Expertise in ms office ,word,excel
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