Job Title: Manager | CSV | Mumbai | SAP
· 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