Description
I'm urgently looking for Lab Systems Data Integrity Specialist for a contract potition based in the Netherlands
Responsibilities include but are not limited to:
- Assist management in the development and execution of plans required to address corporate data integrity system gaps for business applications.
- Drive system compliance and data integrity, set expectations and goals, and implement and optimize processes
- Installation of Secure Desktop on the standalone PC and configuration of the same
- Collaborate with System Owner to develop Design Qualifications, Functional Requirements, User Requirements, IQ/OQ/PQ etc.
Identify and complete Data Integrity-related deliverables and activities in regard to corporate SOPs and current regulations for business applications such as:
- Verify that data integrity related data is captured in Audit Trails. Identify the types of audit trails that need to be captured and how often to review.
- Identify system integrations from the primary system of record and critical data flows between them.
- Perform Data Mapping for critical data, metadata and data flow through the data life cycle for stand-alone and integrated systems.
- Perform scheduled reviews of existing systems and delineate remediation plans for non-conformances
- Maintain Systems records and updates
- Identify process improvement opportunities, develop and revise SOPs, and lead departmental initiatives
- Provide QA sign off on system release, track system trends, and complete risk assessments
- Demonstrated leadership skills with a proven track record of driving continuous improvement
- Excellent communication and interpersonal skills with the ability to influence others with impact
- Advanced knowledge of system vulnerabilities and security issues.
- Manage the configuration and operation of client-based computer operating systems
- Good knowledge & application of FDA regulatory requirements and industry standards related to cGMP document management.
Qualifications:
Education Requirement:
- Bachelor's Degree in Computer Science, Management Information Systems or equivalent degree.
Required Experience and Skills:
- Atleast 3 years performing in the IT Quality and Compliance and/or data integrity roles.
- Thorough knowledge of ERES (21 CFR Part 11 and Annex 11) and Data Integrity (including MHRA, FDA regulations and guidelines).
- Strong understanding and experience interpreting data integrity regulatory requirements and data governance principles.
- Evidence of using this knowledge to create training materials/perform effective training of individuals on data integrity/data governance principles and the performance of CSV to ensure data integrity.
- Experience evaluating, designing/redesigning business rules, processes, definitions, quality expectations and checks & balances to ensure data integrity in a scalable and efficient manner.
- Thorough knowledge of IT Controls methodologies, including GAMP5 and ITIL.
- Excellent communication skills in Spanish and English, both verbal and written.
- Detailed knowledge of the IT system development life cycle and software quality assurance in a regulated environment.
- Knowledge of general software and database concepts.
Preferred Experience and Skills:
- At least 4 years of experience working in a similar position within a business regulated environment
- Secure Desktop installation & configuration
- Familiarity with project management practices
- Experience with risk analysis, risk management and computer system periodic review practices and tools.
- Knowledge of infrastructure technology and platforms.
- The ability to management projects, work independently and with teams at various levels in the organization in waterfall and agile environments.
- Excellent organizational and problem solving skills and attention to detail and accuracy.
Interviews ongoing, apply now for immediate consideration!