JacksonGrantที่อยู่142 Two Pacific Place, 18th Floor, Unit1805, Sukhumvit Road, Klongtoey, Klongtoey Bangkok 10110
ชื่อผู้ติดต่อ-
โทรศัพท์0-2653-3998 Fax 0-2650-9014
เว็บไซต์
JacksonGrantJacksonGrant
- Gathers Business Requirements and prepares FDA compliant documents based on those requirements.
- Interacts with business community and customers to understand business process and define tools can be leveraged to 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, analyze 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.
- In-depth knowledge of development process.
- Ability to Identify, gather, analyst and properly document system requirements.
- Capable of ensuring that documents plus practices attain quality standards and applicable regulatory conformance.
- 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 Databases 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 is an asset.
- Proven skills in project management.
- Organization and time management.
- Excellent technical knowledge in specialized domains.
- Knowledge of development in an Windows Client/Server Platform or Unix Client/Server Platform
- Duties of this position are performed in a normal office environment.
- Duties may require extended periods of sitting and sustained visual concentration on a computer monitor or on numbers and other detailed data.
- Repetitive manual movements (e.g., data entry, using a computer mouse, using a calculator, etc.) are frequently required.
- Occasional overnight travel is required.
- 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 Part 820, 210, 211, 21 CFR Part 11, ISO 13485, ISO 14971.
- Bachelor degree in computer software, industrial, mechanical engineering or electrical engineering.
- Training in validation methodologies, technologies and process control computer systems.
