*POSITION- Validation Lead LOCATION- Allendale, NJ* *Duration – 12 Months*
· 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. · Experience 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/maintenance & 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. 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 Project 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 * Regards,* *Atul Sharma* IT -recruiter a...@idctechnologies.com <ashw...@idctechnologies.com> Direct: 408.418.5778 <(408)%20418-5778> EXT 3027
