CSV Analyst
- Systechcorp Inc
- 12 - 17 years
- Kolkata
- 11 days ago
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Job Description
Job Description: Validation Lead Responsible for providing validation leadership team management for the development, implementation, and maintenance of Pharma applications in multiple functional areas including Sales & Marketing, R&D, Manufacturing and Supply chain, Enterprise and Corporate. Key Activities
Collaborates closely with the business, IT, and client CSV team to help develop detailed validation timelines and validation plans.
Responsibility for planning, directing, and coordinating validation activities from initiation through to implementation and ongoing support.
Interface and communicate with client and all key stakeholders regarding validation deliverables, project status, risk identification / mitigation and issue management.
Manage GxP and Non-GxP systems change requests, risk, and issues.
Drives the computer validation/qualification activities including developing/reviewing/executing CSV deliverables (Business/Functional Requirements, Risk Assessments, Validation Plans/ Protocols, IQ, OQ, Validation Summary).
Participate in Periodic review of Computer Systems along with Business Owner.
Experience of audit responder to support internal/external Audits.
Provides technical validation expertise, interpretation, and direction to assure compliance with Pharma industry and regulatory requirements in Europe and US, and standards regarding validation, document control, and change management.
Responsible for tracking, monitoring, and controlling the validation process to ensure timely delivery to meet pre-scheduled release dates.
Perform validation impact analysis and risk assessments in conjunction with Application support teams.
Program support through internal audits, system assessment, and inventory management of assets.
Continued improvement of Norgine processes and continued surveillance for draft guidance and regulatory updates. Experience/Skillset Requirements
Degree (Bachelors or Masters) in Computer/Electrical/Electronics Engineering or other relevant Field.
At least 12+ years of experience in the Pharma industry with 6+ years of experience in a Validation Lead role preferably for a Europe based Pharma
Hands-on experience with the validation of commercial, R&D and ERP and Corporate applications used for regulated activities in the pharmaceutical industry
In depth knowledge of FDA/EMA guidelines relevant to 21 CFR Part 11, EU Annex 11 compliance requirements, medical device standards and Global Computer System Validation and ISPE GAMP guidelines
Knowledge of Agile software development, and software testing methodologies.
Excellent written and oral communication skills, good decision-making skills, and time management skills.
Experience with cloud-based applications and/or infrastructure compliance
Additional Sills:
Job Classification
Industry: IT Services & ConsultingFunctional Area / Department: Data Science & AnalyticsRole Category: Business Intelligence & AnalyticsRole: Business AnalystEmployement Type: Full timeContact Details:
Company: Systechcorp IncLocation(s): Kolkata
Keyskills: Supply chain Computer system validation ERP Change management Application support Team management Agile Monitoring Electronics engineering Auditing
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Systechcorp Inc
SysTechCorp Inc provides leading-edge technology services that empower our clients to meet and exceed their strategic business objectives. Our AI, ML, Mobile, Cloud, and ERP practice is backed by years of experience and deep domain expertise in a wide range of industry verticals.
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