Hi , If you have anyone with you for the following position, please send the suitable resume along with Contact Details,
Kindly share suitable resumes ASAP to sanjay.ya...@nityo.com *Role : Validation Lead* *Location : Allendale, NJ* *Experience : 7+years* Technical/Functional Skills: • Very good experience is SDLC and Computer Systems Validation (CSV) • Agile Methodology experience preferred • Supply chain experience preferred. Experience working with SAP ECC preferable. • Infrastructure Qualification experience • High level knowledge working with HPALM • Experience with MS Office applications. • Experien ce working in a cross functional system and within scrum teams. • Experience in Software validation and compliance activities in Pharma (GMP) environment • Experience in working with GxP applications • Experience in creation/mainten ance & implementation of SOPs • Experience in the use of HP Quality Center and similar tools to manage software testing and requirements. • Worked in cGMP, 21 CFR Part11 and GAMP 5 environment • Hands on authoring/ review/ approval of computer system validation deliverables, inclusive of requirements gathering. Functional specification, test/validation plans, protocols, test scripts / cases, traceability matrix and summaries Roles & Responsibilities : • Ensures documentation and practices meet quality standards, applicable regulatory compliance and IS guidelines/policies • Review functional design specification, technical design specifications for clarity, Good documentation practices. • Review the accuracy and completeness of software validation deliverables created by process work streams • Knowledge of software testing. Ability to create Traceability Matrices linking approved requirements to test cases within HPALM. • Create validation deliverables like Requirements, Data Migration Plan, Summary Reports, work instruction documents for tools • Ability to pull necessary details from an object level Technical Design Specs and Functional Design specs and consolidate the information in a Master Technical and Functional Design document that is presentable to an external regulatory agency. • Experience working in an agile environment is preferred • Keep the Program Validation Lead/Validation Proj ect Manager informed of any issues regarding the quality of deliverables or any potential sources of impact to the project timeline. • Report on the status of validation deliverables and support other compliance work as necessary Generic Managerial Skills : • Very good communication skill with strong customer relationship management skills • Proactive and Innovative. • Good analytical skills. Should be able to evaluate a situation and take right decisions. • Should be able to own the activities and drive for completion. • Capabilities to host meetings, capability of handling multiple projects, multiple stakeholders and Conflict resolution. CSV, Validation Lead, GxP, Agile, ERP implementation ** *Thanks & Regards,* *Sanjay Yadav * Techinical Recruiter *Desk *: 609-853-0818 Ext-2167 *Email*: sanjay.ya...@nityo.com www.nityo.com -- You received this message because you are subscribed to the Google Groups "Oracle Users" group. To unsubscribe from this group and stop receiving emails from it, send an email to oracle-users+unsubscr...@googlegroups.com. To post to this group, send email to oracle-users@googlegroups.com. Visit this group at https://groups.google.com/group/oracle-users. For more options, visit https://groups.google.com/d/optout.
