Candidatul ideal
Knowledge/Skills/Competencies:
- Ability to Identify, gather, analyse and properly document system requirements.
- Capable of ensuring that documents plus practices attain quality standards and applicable regulatory conformance.
- Capable of performing risk analysis using tools such as FMEA
- Capable of implementing software validation engineering test plans, test cases/scripts.
- Ability to propose solutions and collaborate in software validation procedures and processes.
- Proven skills on implementation of computerized system validation projects with 3 years in developing computerized system
- validation plan and protocols.
- Strong written and verbal communication skills with the ability to work through technical issues with customers both remotely and
- in person
- In-depth knowledge of object oriented languages (Java, C++) and or good knowledge of scripting languages (Visual Basic, VB Script,
- JavaScript, HTML, Perl) and relational Data Bases and SQL
- Ability to analyze and understand business requirements and to design solution specifications
- This position requires a high energy level and a passion for excellence.
- Very good command of written & spoken English.
- Good command of written & spoken Spanish preferred
- Proven skills in projects management
- Organization and time management with little overall supervision.
- Excellent technical knowledge in specialized domains.
- Knowledge of development in an Windows Client/Server Platform or Unix Client/Server Platform
- Experience required :
- 3 - 5 years of IT computer validation with experience in medical device manufacturing operation
- experience in a regulated environment with in depth knowledge and experience with cGMPs/GLPs/GAMP regulations related to
- medical device manufacturing systems, CFR PartCFR Part, ISO, IS
- Education:
- Bachelor degree in computer software, industrial, mechanical engineering or electrical engineering. Training in validation methodologies, technologies and process control computer systems.
Descrierea jobului
Job Description:
Incumbents apply in-depth knowledge in a FDA area of specialization. Work is performed within established professional standards and practices. Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors and a considerable degree of judgement. Erroneous decisions or failure to achieve results may have a negative impact on the division’s/department’s operations, schedules, and/or performance goals. Works under minimum Supervision. Seeks approval from others on matters outside of job/role scope. Receives instruction on specific assignment objectives and possible solutions. Unusual problems are solved jointly with manager. Builds internal and external relationships, with emphasis on those that facilitate the achievement of job/role accountabilities, such as relationships with key suppliers, customers and internal service.
Responsibilities&Tasks:
- Gathers Business Requirements and prepares FDA compliant documents based on those requirements.
- Interacts with the business community and customers to understand business processes and define tools can be leveraged to
- optimize the business process.
- Ensures team members are provided with timely and accurate project information and status updates.
- Ensure all systems are running in compliance with company and site policies
- Plan, Analyse and document tests for Manufacturing Execution Systems and other site systems in compliance with FDA regulations
- Lead application validation
- Manage adjustments or improvements to equipment and processes.
- Lead risk analysis to identify system and process controls.
- Assessment of changes and impact on validated systems
