System Quality Assurance Engineer

LTS is a leading pharmaceutical technology company that develops and manufactures innovative drug delivery systems for the pharmaceutical industry.

LTS´ commercial offering encompasses more than 20 marketed products

LTS operates today from 5 sites: Netanya, Israel, Adrenarche, Germany, West Caldwell, NJ, USA, St. Paul, MN, USA, and Shanghai, China.

We are looking for an excellent QMS Systems Administrator to join our team in Israel.

Job Description:

The QMS Systems Administrator will be a part of the Quality department, and is responsible for managing, maintaining, and optimizing the eQMS platform and other QMS-related systems to ensure the continuous improvement of our organization's quality management processes. In addition, the QMS Systems Administrator is responsible for all computer system validation activities per GAMP 5 and FDA CSV (Computer System Validation) guidelines

Key Responsibilities:

• eQMS Administration

– Manage and maintain the eQMS platform, ensuring its availability, reliability, and optimal performance.

– Collaborate with cross-functional teams to gather system requirements and implement necessary configurations and customizations in the eQMS platform.

– Manage and troubleshoot system issues, working closely with eQMS software vendors to resolve problems and implement solutions.

– Keep up-to-date with eQMS best practices, trends, and technologies, recommending system updates and upgrades as necessary.

– Participate in change management processes related to the eQMS platform, including change requests, risk assessments, and impact analyses.

• Computer system assurance/ validation

– Ensure compliance with FDA CSV/GAMP 5 (Good Automated Manufacturing Practice) guidelines for computerized systems, providing expertise in risk-based approaches for system validation and life cycle management.

– Support the development and execution of CSV/CSA validation plans, protocols, and reports by system owners in accordance with FDA/GAMP 5 guidelines.

• Support other QMS systems as needed

Direct Manager: QMS Manager

Job Requirements:

Education:

o B.Sc in Engineering or practical engineer – life sciences – advantage

o Certified Quality Engineer (CQE) – advantage

Job skills:

• Minimum 3-5 years of experience in eQMS administration (or any other system administration)
• o Strong knowledge of quality management principles, standards, and regulations (e.g., ISO 13485, FDA 21 CFR Part 11, EU Annex 11, GAMP 5 & FDA guidelines for computer system validation/ assurance).
• o Experience in system configuration, customization, and integration.
• o Proven experience with DOT compliance eQMS product – Significant advantage

Computer skills: Full control of all MS-Office applications, salesforce (significant advantage)

• Language English (reading, writing, and speaking) at a high level - mandatory.
• Personality:

At LTS, we value collaboration, innovation, and accountability. We're looking for individuals who can:

Teamwork: Collaborate effectively, embracing diverse perspectives.

Customer Focus: Exceed internal and external customer needs.

Innovation: Create new opportunities with enthusiasm.

Accountability: Take ownership of challenges, uphold standards.

Leadership: Motivate and develop talents, achieving goals.