Job Ref. ID:
Computerized Systems Validation (CSV) Senior Officer
UNITED ARAB EMIRATES
UAE (RAK head office)
Information Technology - Computerized Systems Validation (CSV) Senior Officer
Full Time Employment (Un-limited Contract)
The role Computerized Systems Validation (CSV) Senior Officer provides compliance leadership and direction to business and project teams in Software Development Life Cycle (SDLC) / Computerized System Validation (CSV) / Infrastructure Qualification standards and practices. Role ensures that all computerized systems used to support GMP manufacture are appropriately validated and controlled as per the industry standards.
Key responsibilities & Accountability:
Ensure computerized systems are appropriately documented and validated. Subject matter expert on SDLC/Qualification procedure and able to provide CSV guidance to IT or Business. Leads the team for handling both Quality, Financial Auditors (Internal/External) related to IT GMP and Non-GMP validation with the right kind of approach and strategy. Help project teams define appropriate CSV strategies including stage gate deliverable. Prepare or review all levels of validation documents (internal or external) including: a. Validation (Strategy) Plans, User Requirement Specifications. b. Definition Documents, including Functional Specifications S/W Design Specifications or Configuration Documents and SOPs. c. Qualification Documents and Test Specifications (DQ, OQ, PQ, IQ). d. Traceability Matrices, Risk Analysis. e. Validation Reports, Change Controls/Events/Deviations etc. Provide CSV technical sign-off for all of the above. Reviews, writes, revises and maintain all IT related policies/SOPs and company regulations to team members, system owners and users. Compile and analyze validation data and make recommendations for changes and/or improvements. Contribute and analyze validation data and make recommendations for changes and/or improvements. Contribute directly to the completion of projects through development and execution of validation change control documents and development and review of protocols, reports and data tables generated by peers and contract personnel. Work with the business system owners and teams to support internal and external audits across to confirm compliance of the system with local and regional standards. Performs periodic reviews or re-qualifications to maintain current validation status of softwares and systems as defined by approved validation SOPs.
Bachelor's degree with 8+ years of computerized systems compliance and CSV experienced in life sciences/manufacturing is required.
Experience with Technical Document writing (SOPs) and development. Experience in the review of Validation Deliverables (Project Documentation). Experience with manufacturing automation systems is highly desired.Experience of working with Pharma/Bio-Technology or any manufacturing industry. Proven experience with IT Risk Management and Control policies and procedures.
- Specialized Knowledge and Skills:
Understanding of GxP and Computer Systems/Automation role in support of GxP compliance is required. Risk-based approach to compliant GxP computerized systems. Understanding of GAMP5 and risk-based approach to validation is required. Knowledge and understanding of relevant regulations such as Part 11, Annex 11, Part 211 is required. Ability to identify, define and propose the quality framework improvements based on daily challenges is desired. Excellent communication and written skills required.Ability to manage and/or coordinate projects from start to completion in Quality Compliance field. Participate on cross functional teams to validate/verify, implement, and maintain regulated (Example: GxP, JSOX, etc.) and/or non-regulated systems. Proficiency in MS Office Tools. Knowledge in Documentation Life Cycle and Good Documentation Practices
AccountabilityAnalytical ThinkingCommunicating in WritingCommunicating OrallyContinual ImprovementContinual LearningCustomer FocusEmotional IntelligenceEstablishing FocusFlexibilityInfluencing OthersInitiativeInnovationInterpersonal SkillsSolving ProblemsSystems ThinkingTechnical CredibilityTechnology Use/ManagementThinking StrategicallyValuing and Leveraging Diversity
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