Job
Description
We are seeking an experienced professional for the role of Assistant Manager, Computer System Validation (CSV) to join our Risk Advisory team. The ideal candidate will have a strong background in computer system validation within the life sciences and pharmaceutical industry, with a deep understanding of regulatory requirements and validation methodologies. Job Description- Computer System Validation (Assistant Manager) At least 6-7 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 knowledge 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 point. 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 Ability to lead projects end-to-end, including stakeholder management as a part of delivering services involving multiple stake holders with diverse interests, knowledge, cultural background, and personality. Manage multiple concurrent tasks and be flexible. Experience in facing internal quality audits, vendor audits and also providing support during audits by external auditors like US FDA in validation perspective. 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 Equal employment opportunity information KPMG India has a policy of providing equal opportunity for all applicants and employees regardless of their color, caste, religion, age, sex/gender, national origin, citizenship, sexual orientation, gender identity or expression, disability or other legally protected status. KPMG India values diversity and we request you to submit the details below to support us in our endeavor for diversity. Providing the below information is voluntary and refusal to submit such information will not be prejudicial to you.
