LSCON SAP Computer System Validation Business Consulting
Job Location:
Foster, CA - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
We are looking for people who have demonstrated proven success in roles and through abilities in Computerized System Validation for ERP applications like ECC/SAP S/4 HANA Cloud Validation Risk management and Quality Management. The candidate will have to perform validation service activities related to ECC to SAP S/4 HANA transformation or SAP implementation program.
Key Responsibilities
1. Own and drive CSV activities for SAP ECC to SAP S/4HANA transformation programs and new SAP implementations.
2. Ensure validation activities comply with regulatory and company quality requirements.
3. Define validation frameworks and lifecycle methodologies for SAP S/4HANA programs.
4. Ensure compliance with 21 CFR Part 11 GxP Regulations GAMP 5 Data Integrity requirements Data Privacy regulations Information Security standards and SOX IT controls
5. Create review approve and maintain-Validation Plans (VP) User Requirements Specifications (URS) Functional & Design Specifications Risk Assessments IQ/OQ/PQ documents Traceability Matrices Validation Summary Reports (VSR) and SOPs and related quality documents
6. Collaborate with client Quality Compliance and Validation teams.
7. Work closely with SAP functional and technical teams across modules such as: Finance (FI/CO) Supply Chain Manufacturing Procurement Quality Management and Master Data Governance (MDG)
Basic Skills & Experience
Minimum of 3 years of professional experience in Life Sciences industry working for a consulting services organization and/or industry experience.
Experience creating reviewing and approving / acknowledging validation deliverables.
Knowledge of risk management process and quality management requirements which assures that IT Projects meet Quality and Regulatory requirements
Understanding of key pharmaceutical compliance regulations like Computerized System Validation 21 CFR Part 11 GxP GAMP 5 SOX IT Cloud S4 Data Privacy Data Integrity and Information Security
Work with project management to build an integrated project plan inclusive of the required Computer System Validation (CSV) Lifecycle Deliverables quality gates and summarization milestones.
Knowledge on basic function on SAP workstreams/modules
Knowledge of various tools/applications used in SAP implementation program Like Solution Manager CHARM SAP GRC DRC SAP MDG SAP Rise Data migration tool (SNP ADM etc.)
- Candidates authorized to work for any employer in US without employer-based visa sponsorship are welcome to apply. Infosys is unable to provide immigration sponsorship for this role at this time
- Location: Foster City California
Strong understanding of pharmaceutical compliance regulations and validation concepts.
Experience of having led large S/4 HANA transformation programs from a Validation Lead perspective
Experience with Agile and Waterfall methodologies.
Familiarity with tools like ServiceNow JIRA Veeva HPALM.
Ability to manage multiple projects and adapt to complex environments.
IT background preferred to understand program complexities.
Excellent communication and collaboration skills.
Benefits
Along with competitive pay as a full-time Infosys employee you are also eligible for the following benefits:
- Medical/Dental/Vision/Life Insurance
- Long-term/Short-term Disability
- Health and Dependent Care Reimbursement Accounts
- Insurance (Accident Critical Illness Hospital Indemnity Legal)
- 401(k) plan and contributions dependent on salary level
- Paid holidays plus Paid Time Off
About Us
Infosys Consulting is a next-generation consulting partner that bridges strategy and execution. With an AI-first mindset deep industry knowledge and the combined strengths of business and technology consulting it helps enterprises turn bold vision into tangible outcomes faster smarter and at scale. Infosys Consulting is helping some of the worlds most recognizable brands transform and innovate. Our consultants are industry experts that lead complex change agendas driven by disruptive technology. With offices in 20 countries and backed by the power of the global Infosys brand our teams help the C-suite navigate todays digital landscape to win market share and create shareholder value for lasting competitive advantage.
EEO
Infosys provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy childbirth or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability.
About Company
Welcome to Infosys Careers for Experienced Professionals As a leading provider of next-generation consulting, technology and outsourcing solutions, we are dedicated to helping organizations in over 46 countries to renew their core and simultaneously innovate into new frontiers. Whilst ... View more
