Consultant | CSV | Hyderabad | SAP | DSA LS&HC
• Job requisition ID : 111880
• Location: Hyderabad
• Entity: Deloitte Touche Tohmatsu India LLP
The team
Enterprise technology must do much more than keep the wheels turning; it is the engine that drives functional excellence and the enabler of innovation and long-term growth. Learn more about ET&P
Your work profile
Experienced Computer System Validation (CSV) and Quality Assurance professional with 5+ years of expertise in validating GxP-regulated computerized systems within the Life Sciences and Healthcare industry. Proven track record of leading end-to-end validation activities for enterprise applications including ERP, LIMS, QMS, MRP, and cloud-based platforms.Key skills required
· 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 AI/ML Validation
- 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
Education: BE/Btech/Any fulltime graduation