Description
Job Details:Job Title: Lab Systems Data Integrity Specialist(Pharmaceutical Operations Facility)
Job Type: Contract
Job Locations: Salamanca ,Spain
Job Description:
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.
o Identify system integrations from the primary system of record and critical data flows between them.
o Perform Data Mapping for critical data, metadata and data flow through the data life cycle for stand-alone and integrated systems.
o 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: ?
• Atleast 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.