CSV Consultant

Job Overview:

• A typical day for an Infoscion
• As a member of the Infosys consulting team, your main responsibility will be to support the consulting team throughout various phases of projects, which include defining problems, estimating efforts, diagnosing issues, generating solutions, and overseeing design and deployment.
• You will investigate alternatives to recommended solutions by conducting research, which involves literature reviews, public domain information, vendor evaluations, and more.
• Additionally, you will develop Proof of Concepts (POCs).
• Your role will involve creating requirement specifications that stem from business needs, defining "to-be" processes, and crafting detailed functional designs based on those requirements.
• You will assist in configuring solution requirements on products, understanding potential issues, diagnosing root causes, seeking clarifications, and identifying and evaluating solution alternatives.
• Furthermore, you will contribute to both unit-level and organizational initiatives aimed at delivering high-quality, value-adding solutions to our clients.
• If you believe you can help our clients successfully navigate their digital transformation journey, we encourage you to apply.

Core Responsibilities:

• The following are key aspects of the role, though not exhaustive:
• 5 years
• of professional experience with a strong foundation in IT Quality Compliance, Computer System Validation, Software Testing, and System Implementation within the Life Sciences sector.
• Lead efforts to manage and maintain the validation of GxP computerized systems.
• Develop Validation Plans, Validation Reports, and review validation documentation such as URS, FS, FRA, DD, IQ, OQ, PQs, and TRM.
• Ensure compliance with GxP, GMP, GCP, GLP, and privacy regulations.
• Create and maintain IT GxP compliance documentation.
• Verify that GxP Computerized Systems are validated according to GAMP 5 standards.
• Manage stakeholders effectively and demonstrate strong communication skills.
• The candidate should possess a solid conceptual understanding of the following key areas:
• o IT QMS
• o Validation Qualification
• o Risk Management
• o Defect/Deviations Handling
• o Investigations
• o CAPA Management
• o Test Management Compliance
• The candidate must be knowledgeable about current regulations such as 21CFR Part 11, EU Annex 11, and guidelines like GAMP5.
• The candidate will provide application validation expertise across various scenarios, including standalone and enterprise cases.

Technical Skills:

• Primary skills required: Domain Life Sciences, Life Sciences ALL

Additional Duties:

• Capability to develop strategies and models that create value, enabling clients to innovate, drive growth, and enhance business profitability.
• Strong understanding of software configuration management systems.
• Awareness of current technologies and industry trends.
• Logical reasoning and problem-solving skills, alongside a collaborative approach.
• Comprehension of financial processes related to various project types and available pricing models.
• Ability to evaluate current processes, identify areas for improvement, and recommend technology solutions.
• Knowledge of one or two industry domains.
• Strong client interfacing skills.
• Experience in project and team management.

Preferred Qualifications:

• Domain: Life Sciences
• Pharma Regulations: Computer Systems Validation (CSV)