Qualification Required: BACHELOR OF ENGINEERING
Skills Required: Quality Management for Delivery
Hands on Experience in Software validation and compliance activities in pharma (GMP) environment, Experience in the pharmaceutical or biotech industries supporting IT initiatives, Experience in working with GxP, SOX, Data Privacy applications, Experience in the use of HP Quality Center and similar tools to manage software testing and requirements. 1. Experience in Information Technology, hands on computer system validation activities. 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. Experience in the pharmaceutical or biotech industries supporting IT initiatives, Demonstrated skills for independently guiding quality and compliance activities during system application design, development and deployment in the pharma industry. Demonstrated ability to communicate effectively with individuals and groups at multiple levels across the organization, Ability to work independently, manage multiple priorities, and work in an unstructured environment, Experience managing activities within medium to large scale IT projects, Experience with risk based approaches to validation (GAMP 5), Excellent oral and written communication skills.