Automation & Data Integrity Specialist

As an Automation & Data Integrity Specialist in Netherlands, you will:

The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance.

Individual contributor who is a developing subject matter expert, who works independently with minimal supervision. Directs groups in activities related to the organization's Data Integrity processes and procedures, from implementing quality standards through developing internal processes that optimize the Data Integrity function. Identifies compliance issues, supports in developing corrective action plans, and collaborates cross-functionally to implement new quality control procedures.

Coordinates inspections to ensure Data Integrity compliance with established companies and regulatory standards.

The responsibilities and the impact YOU will have:

• Act as a Data Integrity (DI) specialist and monitors DI compliance during implementation of analytical equipment, applying ALCOA + guidance through all QC processes.
• Pertain advanced subject matter expertise on Data Integrity standards.
• Identifies DI issues, creates and owns Quality Risk Assessments, reviews result of quality audits and regulatory inspections and provides support in developing corrective action plans.
• Consults on newly developed testing procedures and other procedural changes.
• Coaches and trains colleagues in DI compliance
• NC/CPA DI Quality Lead/Owner
• Deploys and owns AT Site DI Gemba walks
• Leads Data Integrity governance process
• Provide DI Inspection readiness guidance. Support Internal/External Audits
• Provide DI assessment during equipment validations (e.g. audit trail validations etc)
• Provide DI guidance during Change control process
• Adhere to compliance best practices, EHSS regulations and lean principles.
• Perform other work-related activities assigned by supervisor.

We would love to hear from YOU, if you have the following essential requirements:

Bachelor’s degree (or equivalent) in a relevant discipline with 2-4 years of related working experience.

In addition:

• Didactical skills to effectively transfer information in a training environment.
• Experience in troubleshooting, advanced equipment/system knowledge.
• Acting as Subject Matter Expert during audits and inspections.
• Responsible for related deviation management and coordinator of appropriate corrective/preventive actions.

Preferred Skills:

Coaching, Communication, Compliance Management, Controls Compliance, Econometric Models, ISO 9001, Performance Measurement, Problem Solving, Process Oriented, Quality Auditing, Quality Control (QC), Quality Standards, Researching, Standard Operating Procedure (SOP), Technologically Savvy

Hybrid Work