Senior Consultant | CSV | Bengaluru | SAP

Job Description :

RESPONSIBILITIES / ACCOUNTABILITIES

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  Should have at least 5 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 5 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.
• 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 SDLC.

PERSONAL ATTRIBUTES

• 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
• Inspire and motivate team