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Validation Specialist
2 months ago
About Us
We are a leading provider of software and services to the Pharmaceutical, Medical device, and Cannabis industries. Our company offers validation services as well as the sale and implementation of our in-house software Validator, a tool for automation in Compliance. With nearly 20 years in operation, we pride ourselves in always providing excellent, professional, and knowledgeable consultants for each of our clients. We offer a competitive compensation package with benefits.
Purpose
We are seeking a Senior Validation Consultant to become an integral part of our team. You will service domestic and international clients, as well as support in-house software.
Key Responsibilities:
- Develop and implement qualification and validation strategies for computer systems and IT infrastructure.
- Work with Laboratory Information Management Systems (LIMS), Lab Execution Systems (LES), and Manufacturing Execution Systems (MES) to ensure compliance with regulatory requirements.
- Install and validate chromatographic instruments and related software systems, and general pharmaceutical quality control and R&D laboratory instrumentation/equipment.
- Implement software solutions, computer system validation, equipment qualification in regulated cGMP/GxP environments.
- Ensure compliance with GxP and regulatory Data Integrity requirements (ALCOA+).
- Stay up-to-date with GAMP, FDA, ICH, and other relevant regulatory requirements in the MedTech and Pharma industries.
- Develop and maintain Change Control and Quality Documentation in the MedTech and Pharma Industries.
- Conduct CSV and IT infrastructure qualification and validation activities and deliverables.
- Develop Validation Project Plans (VPP), IQ, OQ, PQ protocols, and Validation Summary Reports (VSRs).
- Apply System Development Life Cycle (SDLC) principles.
- Work with corporate Quality Management Systems, current Good Manufacturing Practices (cGMP), and Good Clinical Practice (GCP).
Requirements:
- Graduate degree in Computer Science, Engineering, Information Systems, or related technical field or 10+ years direct, relevant CSV experience in MedTech or Pharmaceutical Quality Control and/or R&D.
- Strong computer, scientific, and organizational skills.
- Strong root-cause analysis skills.
- Deadline and detail-oriented.
- Strong communication skills.
- Ability to travel within North America and abroad.
