In an increasingly interconnected and regulated world, the role of IT Quality Assurance and Compliance Specialists has never been more crucial. As businesses navigate evolving international regulations, maintaining compliance, ensuring data integrity, and meeting validation standards is imperative. Sartorius, a global leader in scientific technology, is seeking skilled professionals to fill this pivotal role, offering a unique opportunity to work at the intersection of technology, quality assurance, and compliance.
If you are an experienced professional passionate about computerized system validation (CSV), data integrity, and IT compliance, this role is the perfect platform to showcase your expertise while contributing to transformative scientific advancements.
About the Role: IT Quality Assurance and Compliance Specialist
As an IT Quality Assurance and Compliance Specialist, you will take the lead in ensuring that Sartorius’ IT systems and processes meet international compliance standards. Your role will involve implementing and updating compliance guidelines, validating critical IT systems, and working with cross-functional teams to maintain the highest standards of data integrity and application performance.
Your expertise will help ensure that Sartorius’ IT infrastructure supports groundbreaking scientific research and healthcare solutions.
Key Responsibilities
The role encompasses a range of responsibilities critical to maintaining compliance and validation in a complex IT landscape. Below is an in-depth look at what this role entails:
1. Application Validation
- Validate IT applications and infrastructure to ensure alignment with compliance standards and corporate guidelines.
- Perform data integrity checks and assessments to safeguard system reliability.
2. Development of Validation Documents
- Prepare comprehensive validation documentation, including:
- Validation plans
- User Requirements Specifications (URS)
- Functional Specifications (FS)
- Risk assessments
- Test plans
- Traceability matrices
- Validation reports
3. Stakeholder Collaboration
- Act as a Subject Matter Expert (SME), supporting System Owners and Process Owners in their compliance efforts.
- Lead workshops and discussions to evaluate and implement data integrity measures.
- Collaborate with stakeholders across IT, quality assurance, and business units.
4. Supplier Qualification
- Conduct Computerized System Validation (CSV) supplier qualification processes to ensure vendor compliance with international standards.
5. Personnel Training
- Train team members and stakeholders on validation processes, standards, and compliance requirements.
6. Change Control and Periodic Reviews
- Monitor and manage change control processes to align with updated regulations.
- Conduct regular periodic reviews of systems to ensure continued compliance.
Skills and Requirements
1. Professional Experience
- Several years of experience in (CSV):
- Experience in cloud infrastructure qualification, AI validation, and application validation.
- Proficient in ensuring adherence to global regulatory standards, including:
- EMA (European Medicines Agency)
- FDA (Food and Drug Administration)
- ISO 13485
- GMP (Good Manufacturing Practices)
- GAMP5 (Good Automated Manufacturing Practice)
2. IT System Knowledge
- Strong understanding of IT systems and landscapes, including knowledge of SAP.
- Familiarity with GAMP5 processes and how they align with business needs.
3. Interpersonal and Communication Skills
- Ability to explain complex information in simple, accurate terms to diverse stakeholders, including those from business, IT, and quality assurance teams.
- Excellent documentation skills for validation and compliance processes.
4. Educational Qualifications
- University degree in Information Technology or an equivalent field.
- Comparable qualifications in IT validation or infrastructure qualification.
5. Language Proficiency
- Fluent business English proficiency at B2/1 level or higher.
Why Join Sartorius?
1. Impactful Mission
Sartorius is committed to accelerating scientific discoveries and delivering healthcare solutions to patients worldwide. By joining the company, you become a part of a global mission to fight diseases such as cancer and dementia, helping bring innovative therapies to market faster.
2. Career Growth Opportunities
Sartorius offers a dynamic and collaborative work environment where ambitious professionals can advance their careers. The company values creativity, innovation, and team collaboration, making it an ideal workplace for career-oriented individuals.
3. Work on Cutting-Edge Technology
In this role, you will work with the latest IT systems, validation tools, and compliance technologies. This is a chance to enhance your skills while contributing to the technological backbone of scientific breakthroughs.
4. International Exposure
As a global organization, Sartorius provides opportunities to interact with international teams, work on global compliance projects, and gain insights into worldwide regulatory practices.
Key Responsibilities in Detail
A. Application Validation and Data Integrity
- Ensure that applications meet data integrity standards by performing thorough validations. This includes understanding and implementing compliance regulations from organizations like the FDA and EMA.
B. Document Preparation
- Develop detailed validation documentation to demonstrate compliance. Each document must be clear, accurate, and aligned with corporate standards.
C. Stakeholder Engagement
- Provide guidance to System Owners, ensuring their systems comply with validation protocols. Collaborate with other teams to streamline processes and achieve compliance efficiently.
D. Training and Knowledge Sharing
- Train personnel in validation standards, fostering a culture of compliance and quality within the organization.
What Sets Sartorius Apart?
1. Commitment to Excellence
Sartorius is renowned for its steadfast dedication to quality and innovation. By joining the company, you will align yourself with a leader in the scientific and healthcare sectors.
2. Collaborative Environment
The company encourages collaboration among its diverse teams, ensuring that every voice is heard, and every contribution matters.
3. Competitive Compensation and Benefits
Sartorius offers a competitive salary package, professional development opportunities, and a chance to work on impactful global projects.