Csv Consultant

Role & responsibilities

• At least 4-5 years of computer system validation experience in a Life sciences and pharmaceutical environment.
• Good knowledge of cGxP regulations and software lifecycle approaches (e.g., 21 CFR part 11, EU Annex 11, GAMP 5, SDLC Waterfall/Agile methodologies)
• Having good understanding on Computer system Assurance (CSA)
• Experience in the validation of software and tools in a FDA regulated environment. (e.g, SAP, Solution Manager, EDMS, LIMS, PLC/SCADA systems etc.)
• Good to have experience on infrastructure qualification documentation- QP, IS, IQ, RTM
• Basic understanding of cyber security, Public Cloud Platforms such as AWS, Azure, IT Network components is a plus.
• Experience of authoring and reviewing validation documentation and SOPs to maintain compliance
• Ensure documentation and practices meet quality standards, applicable regulatory compliance and company guidelines/policies as per cGxP
• Experience in risk assessment during the implementation and operation of IT solutions.
• Define risk-based strategies for the validation of the systems, which includes but not limited to validation methodologies, testing activities, documentation, and SOPs.
• Review the accuracy and completeness of software validation deliverables created by other process teams CSV deliverables like of Gap Analysis, Remediation Plan, Change Control Management, Risk Assessment and validation documentation like SOPs, Validation Plan, User Requirements Specification, Qualification Plans, Validation Summary Report, Traceability Matrix, IQ/OQ/PQ Test Protocols for accuracy, consistency, clarity, and completeness
• Understand Deviation, how to perform its investigation and propose CAPA for the deviation.
• Handled change management and aware of writing change requests.
• Experienced in working with validation tools such as HP ALM/Validator/Valgenesis
• Manage multiple concurrent tasks and be flexible.

Mandatory Skills

• 21 CFR part 11, EU Annex 11, GAMP
• MS Office Suite- Word, Excel, PowerPoint
• Good verbal, and written communication skills in English

Good to have

• Knowledge of 21 CFR Part 210, 211, 820, EU MDR, SOX, CSA
• Certifications such as ISO 27001, Cloud certification, Testing ISTQB, TMMi