Lab Systems Data Integrity Specialist

Job Description

Lab Systems Data Integrity Specialist, Pharmaceutical Operations Facility
You will have to ensure the company’s GxP Computer Systems are implemented within GxP requirements within our state-of-the-art pharmaceutical facility.

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 GxP applications.
• Drive system compliance and data integrity, set expectations and goals, and implement and optimize processes
• 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 GxP 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 GxP systems and delineate remediation plans for non-conformances
• Maintain GxP 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:

• At Least 3 years performing in the IT Quality and Compliance and/or data integrity roles.
• Thorough knowledge of GxP and 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 GxP regulated environment
• 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.