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CSV/CSA Compliance Coordinator
vor 2 Monaten
Objective of the Role:
The CSV/CSA Support and Validation Coordinator is responsible for maintaining the integrity, quality, and compliance of the GPDM Polarion Tool through comprehensive Computer System Validation (CSV) and Computer Software Assurance (CSA) processes. This position involves collaboration with the CSV/CSA lead, coordinating activities across various global teams, and ensuring adherence to regulatory and internal standards. The Coordinator will be instrumental in planning, executing, and documenting validation efforts while facilitating effective communication between ALM, PLM, and ERP systems.
Key Responsibilities:
- Facilitate CSV/CSA initiatives for the GPDM Polarion Tool.
- Support the CSV/CSA lead within the Global PDM Team.
- Organize and coordinate all CSV/CSA efforts among FMC CSV/CSA teams (EMEA and NA) to enable synchronized system releases across FME.
- Assist in the technical writing and development of CSV/CSA documentation based on contributions from work streams and FMC global topic leaders.
- Oversee CSV activities for ALM systems and manage interactions between ALM, PLM, and ERP systems.
- Contribute to the creation and revision of the PCP to ensure alignment with CSA protocols.
- Help address CSA discrepancies and provide training to project team members on CSA-related subjects.
- Ensure all CSA documentation adheres to good documentation practices (GDP) and is organized in the appropriate sequential order.
- Conduct quality gate reviews and validate business-critical activities prior to business go-live.
- Develop and manage the go-live approval sheet (GLAS).
- Maintain CSA documentation for regulatory assessments and oversee all CSA activities.
- Provide technical writing assistance for CSA documentation.
Qualifications:
- Bachelor's degree in Engineering, Computer Science, Information Technology, or a related discipline. An advanced degree (Master's, PhD) in a relevant field is preferred.
- Further education or certification in Computer System Validation (CSV), Computer Software Assurance (CSA), or related fields is highly desirable.
- A minimum of 5 years of experience in CSV/CSA activities and IT system validation, ideally within a regulated industry such as medical devices, pharmaceuticals, or biotechnology.
- Extensive background in program/project management and quality assurance in a regulated setting, with a solid understanding of FDA Quality System Regulations (QSR), 21 CFR Part 11, and GAMP5 guidelines.
- Demonstrated success in managing multiple validation projects and collaborating with cross-functional teams.
- Strong analytical and problem-solving capabilities with the ability to oversee complex validation tasks.
- Excellent communication and interpersonal skills, adept at collaborating with global teams and stakeholders.
- High attention to detail and a commitment to quality and compliance.
- Ability to work independently and take initiative in a fast-paced, dynamic environment.
- In-depth knowledge of ALM (Application Lifecycle Management), PLM (Product Lifecycle Management), and ERP (Enterprise Resource Planning) systems.
- Familiarity with tools such as Polarion, Windchill, Thingworx, and Azure DevOps.
- Proficient in English; proficiency in German is an advantage.
- Advanced skills in digital technologies and IT systems pertinent to CSV/CSA activities.
- Awareness of industry best practices and regulatory requirements for system validation in a global context, particularly regarding Windchill and Polarion.
- Willingness to travel globally up to 20% of the time.
- Flexibility to work varied hours, including weekends or shifts, as necessary to meet project deadlines.
Company Culture:
At Fresenius Medical Care, we are dedicated to creating and delivering treatments that improve and save lives. We support your ongoing development and foster a collaborative environment where team members inspire one another to achieve optimal healthcare outcomes daily.
Diversity and Inclusion:
Joining Fresenius Medical Care means becoming part of a diverse team that values different backgrounds, cultures, experiences, and perspectives. We strive to cultivate an inclusive atmosphere where all employees feel appreciated.
Stability and Growth:
We are recognized as the market leader in the production of hemodialysis machines, driven by sustainable and profitable growth. This position offers our employees the stability and security needed to enhance the lives of our patients.
Learning and Development:
We provide opportunities for participation in programs at prestigious business schools, leadership development, regular training for healthcare professionals, and digital access to high-quality educational resources for all employees worldwide.
Work-Life Balance:
We empower our team members to deliver exceptional care by promoting a healthy work-life balance through flexible working hours, part-time options, and remote work opportunities.
