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Senior Validation Specialist
Il y a 5 mois
Responsibilities
75%: Providing validation consulting services and project management for Waters software products in a customer-facing capacity. This includes:
Working with Waters customers from pre-sale stage to understand and clarify requirements. Turning customer requirements into the necessary validation deliverables. Performing gap analysis, developing validation plans, and managing customer expectations. Providing validation consultancy expert advice to customers to help guide them through the validation process. Assisting in the development, implementation, and maintenance of computerized system’s state of validation and compliance throughout its SDLC. Author and/or review high-quality CSV deliverables such as Validation Plans, Test Plans and Validation Summary Reports. Assisting the authoring and execution of validation documents (g., System Testing, IQ, OQ, PQ, UAT) for GxP regulated computerized systems. Performing Data Integrity, Qualification and FDA 21 Part 11 assessments. Reviewing, editing, and approving validation documentation and test results. Assisting in computerized systems change management control and periodic review processes.15%: Pre-sales involvement and revenue generation. This includes:
Contributing to efforts for reaching regional financial Informatics CSV targets. Identifying opportunities for selling validation consulting services. Working with sales to develop proposals for validation services delivery which involve cost and effort estimation and scope definition (Statements of Work). Providing and delivering training in computer systems validation knowledge to sales and account managers.10%: Contributing to the establishment and maintenance of a CSV centre of excellence. This includes:
Collaborating with peers and external regulatory bodies on improving Waters overall compliance and CSV strategy. Actively following up on updates from Regulatory and Compliance organizations to best advise internal and external customers on changing trends and requirements. Reporting to management such issues as non-conforming products, conflicting priorities, and/or resources in meeting expected validation deliverables. Commitment to be a subject matter expert in at least 2 core Waters Software products.
Qualifications
MSc in Computer Science, Engineering, Chemistry, or other science related field. In-depth knowledge of validation deliverables associated with each step of the computer system lifecycle. Thorough understanding of industry standards and applicable regulatory guidance and rules, ., 21 CFR Part 11, Annex 11, Annex 15, GxP, ISO/IEC/IEEE. A basic technical understanding of the overall computerized system, including networking, client/server concepts, and understanding details around the deployment of an oracle-based data acquisition system. Previous experience working as a billable validation consultant is desirable. Ability to work under pressure against tight deadlines. Strong interpersonal skills:Must possess a strong customer focus/passion.Demonstrates a “can do” attitude and presents themselves as an ambassador of Waters in the most professional way.Proven excellent communication skills, including in remote environment.Embraces training and support to facilitate continuous learning of Waters products, services, and customer satisfaction methodologies.Self-motivated with good organizational/time management skills and ability to work with minimum supervision. Language skills Fluent in French and English. Other EMEA languages is a valued advantage.Superior written and verbal communications and presentation skills for multiple audiences including users, technical team, vendors, and customer auditors. Software application skillsOffice 365 Suite, including MS Project, Visio.Empower, waters_connect and NuGenesis product knowledge is an asset.Knowledge of Cloud Technology (AWS, Azure, Google) a nice to have.Knowledge of LIMS and other laboratory platforms is an advantage.