Location: Tarrytown, NY
Start date: 10/01
Category : Full Time
- Perform, record, troubleshoot and analyze temperature mapping of manufacturing equipment using Kaye Validator 2000, Advanced systems (AVS), Data loggers and data traces using Val-suite Pro and track sense Pro.
- Assist in project management by updating equipment information, calibration schedule, preventive maintenance schedule, re-qualification due dates and schedules in Blue Mountain, Update BMRAM (Blue mountain regulatory asset manager), Share point, doc-compliance, process compliance.
- Analyze the situation, perform incident handling and generate deviations, resolve them and implement the new changes in the equipment or process.
- Perform data management for study data of different validation activities.
- Ensure that all the documentation related to quality validation is in compliance with FDA and CGMP regulations and provide technical support to the validation group as needed.
- Perform risk assessments, SWOT analysis, and gap analysis, validate the current state of the equipment, document and analyze the quality standards of the process and equipment.
- Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of issues.
- Develop validation master plans, process flow diagrams, test cases, or standard operating procedures using MS office and MS Visio.
- Prepare, maintain validation and compliance documentation, and conduct validation or qualification tests of new or existing processes, equipment and software in accordance with internal protocols or external standards.
- Bachelor’s in Computer Science or Equivalent is required
- 1-5 years relevant experience
- Strong technical writing to develop client process validations
- Excellent communication skills
- Excellent attention to detail, analytical and problem-solving skills
- Experience with IQ, OQ and PQ protocols
- Knowledge of GMPs