How will you make an impact?
The Data Integrity Compliance Officer ensures that the Quality Laboratories and Operations Department are compliant with industry and corporate data integrity standards as it relates to paper and electronic records.
She or he ensures good documentation practices for electronic and paper based data, is proficient in the application of 21 CFR Part 11 and Annex 11 regulations, and stays current with updates of these regulations.
She or he leads multidisciplinary teams of e.g. laboratory, operations, compliance, validation, quality, and engineering personnel to ensure quality data reporting for the departments and site.
What will you do?
Ensures data integrity practices and procedures are implemented and adhered to for quality compliance and to meet industry standards.
Establishes operational objectives and assists with developing, modifying and executing company policies.
Ensures all new equipment and instrumentation is assessed appropriately and validated for its intended use and existence, usage, and review of audit trails and 21CFR Part 11 and Annex 11 regulations.
Performs risk assessments to determine high risk equipment and audit trails and takes appropriate corrective action.
Assist in sourcing, assessing, and recommending instrumentation / equipment for purchase.
Creates and executes Change Controls for instrumentation / equipment. Aids in establishing user requirements for equipment.
Establishes and chairs the Data Integrity Governance Team meetings. Directs DI Governance team in setting priorities and project assignments.
Communicates actions, compliance gaps, commitments, and status updates to respective areas and to senior management.
Ensures Governance Team deliverables are on target, properly resourced and executed as committed.
Leads departmental data integrity training for all laboratory / production operations to ensure awareness and compliance with data integrity for both paper and electronic records.
Ensures appropriate inspector interaction and good documentation practices.
Develops, manages and updates procedures as necessary to ensure there is clear direction and understanding regarding awareness, responsibilities and the importance of corporate and regulatory requirements and expectations for data integrity.
Routinely evaluates regulatory inspection documents and updates site procedures accordingly. Keeps the DI Governance Team aware of industry trends.
Ensures all software used for the generation of current Good Manufacturing Practices (cGMP) meets the standards required for data integrity compliance.
Establishes and leads a surveillance program to audit all laboratory and operational practices and staff for compliance with established documentation and data integrity standards, practices, and procedures.
Assesses technical responses to questions / issues raised by regulatory agencies and customers. Serves as an advisor to Quality and Operations departments for data integrity matters.
Represents the company as a subject matter expert for data integrity during regulatory and customer audits.
Collaborates on projects to meet customer, business, and regulatory requirements.
Bachelor’s degree in Science, Engineering, or related fields.
At least 7 years experience in a regulated industry, or 5 years with related technical knowledge including data integrity related to quality control data from chromatographic systems, knowledge of laboratory instrumentation and / or operations equipment and associated computer systems.
Knowledge, Skills, Abilities
Strong knowledge of current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP).
Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
Effective written, interpersonal, and presentation skills.
Fluent in English and Dutch language.
Ability to work on multiple projects simultaneously.
Ability to drive functional, technical and operational excellence.
Ability to inspire and foster innovation, collaboration, transparency and team effectiveness.
Project management experience is preferred.
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