Should have at least 7 years of experience in quality assurance and/or computerized system validation processes in a regulated environment in life sciences and healthcare (LSHC) industry.
Knowledge of and experience with regulatory requirements (e.g. GMP, 21 CFR Part 11, 21 CFR Part 820, EU Annex 11 etc..)
Participate as a Validation Subject Matter Expert to support the development of business requirements documentation, technical designs, test strategy and plans, etc.
Responsible to set up the validation strategy to ensure agility & speed in delivery
Minimum of 7 years of relevant work experience as a Computer System Validation Professional, including hands-on experience with domain systems (Enterprise Level Application i.e., ERP, MRP, QMS, LIMS, etc.) in support of global business operations
Should be able to defined and execute end to end validation activities for IT projects and system releases/upgrades
Build effective working relationships and collaborate with other domain and enterprise resources to ensure system validation needs are being met.
Should be able to create and review applicable validation deliverables such as GxP Assessment, Validation Plan, URS, FRS, DS, Configuration Specification, IQ , OQ , PQ test plan , test report , Validation Summary Report etc.
Should have experience in performing Data Migration for validated systems.
Exposure to cloud validation , Supplier assessment.
Exposure to Infrastructure Qualification for GxP relevant systems.
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Periodic Reviews of the IT Systems including user reviews and maintaining the validated state of the IT System
Deviation Handling - RCA using 5 x Why approach or any similar approach and CAPA
Experience in handle Change Request during operational phase.
Requirement Risk Assessment , IT Risk Assessments and Data Privacy related tasks
Support Supplier Assessments and provide guidance.
End to end validation activities for IT projects and system releases/upgrades
Define test strategy and review test cases in accordance with test plan.
Support in Internal audit and inspections
Participate in project teams and assist in determining project schedules and the appropriate levels of validation.
Perform validation functional testing as required. Track and resolve deviations during qualification activities.
Test Strategy Definition: Creating a comprehensive testing strategy, including test plans and test data plans across all phases of the SDL
Communication: Excellent written and oral communication skills; able to engage with multiple levels of the organization
Dealing with Ambiguity: Can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; remains calm, effective and practical when dealing with ambiguity; doesn't have to finish things before moving on; can comfortably handle risk and uncertainty
Self Confidence
Good interpersonal skills
Ability to collaborate and communicate with stakeholders and external parties.
Excellent communication skills - written and oral in English
Large degree of flexibility and the ability to work under strong time pressure
Education: BE/Btech/Any full time graduation
Inspire and motivate team
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