Computer System validation Expert
1 month ago
Requirements:Pharma application areas:
Clinical domain, Pharmacovigilance domain and Manufacturing domain ( PV/Argus, CTMS applications, SaaS platform, AWS, manufacturing. QMS)
Experience level :Validation team – 5 years plus
Responsibilities:Partner with key business stakeholders to develop policies and procedures necessary to lead/guide the implementation and maintenance of a compliant, efficient, and integrated CSV program.Perform System Risk AssessmentCreate the end-to-end Validation Plan/StrategyReview Requirement Specifications including Regulatory & non-functional requirements.Review the Technical Design document and solution architecture.Perform Requirement Risk AssessmentAuthor Test PlanReview Pre-executed and post executed IQ, OQ and PQ ScriptsReview IQ/OQ/PQ Summary & Traceability MatrixCreate Validation Summary ReportManage Change ControlsPerform Periodic Review and manage CAPAProvide SME support on topics relevant to GxP, CSV, 21 CFR Part 11, Annex 11 etc.Qualifications:Bachelor's/master’s degree in engineering, Science, Medical or related field.Hands-on experience in Computer System Validation of Applications and Infrastructure Qualification.A minimum of 5-10 years of experience in computer systems validation and hands on experience within GxP (GCP/GMP regulated environment (FDA, EU, MHRA)).Strong working knowledge and experience of global regulations and guidelines such as GAMP, CFR Part 11 Annex 11 and other FDA regulations i.e. 21 CFR Part 210, 211, Part 820, ICH Q9, QSRs, ISO 13485, HIPPA etc. coupled with ability to practically apply such knowledge.Strong knowledge of industry standards like GAMP5, FDA 21 CFR Part 11 on electronic records, electronic signatures etc.A thorough understanding of drug development processes from discovery through development and post-marketing, with an ability to understand business requirements and translate them into practical solutions.
Preferred:Automation: Technical and understands GenAI, automate authoring process, reduction of 20% effort. Standard validation template, generate a plan. Providing more value.
Contact: Rekha for your next career move? Explore opportunities at co-workertech.com
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