A technical writer working within the site Data Integrity project for process automation systems. Implements changes to system documentation following the analysis of data integrity gap assessments, including security, periodic review SOP"s, system design etc.... Executes and reports periodic reviews of process automation and IT systems according to predefined processes. Is competent in the use of an electronic documentation management systems (EDMS). Works with the DI SME to offer guidance regarding data integrity gap remediation actions to the Business and Technical System Owners. Principal responsibilities for the function as a Data Integrity Remediation:
Write and revise site & system SOP"s etc... to include data integrity requirements;
Analyse data integrity gap analysis results, propose and execute remediation actions;
Guides Business and Technical System Owners in current expectation of Data Integrity;
Understands both technical and procedural requirements of Data Integrity;
Familiar with production systems: PLC / HMI / SCADA / MES & standalone systems such as filter integrity testers;
Manages work according to a schedule.
Magnitude & complexity The focus of the function is to execute remediation actions that ensure that the Computerized Quality Systems meet the current requirements of Data Integrity. The complexity lies also in the fact that position operates in a complex, multi-functional, and sometimes multi-site environment, where continuous improvement of the Computerized Quality Systems is required. The position requires a strong analytical and independent thinking and decision making to find structural, regulatory, and business wise sound solutions. Extensive, in depth up-to-date knowledge of manufacturing computerized quality systems and recent developments in this expertise area is a requirement.
Het profiel / Your profile
Requirements & Minimum experience for the function as a Data Integrity Remediation:
Minimum of Bachelor degree or equivalent in computer science or equivalent; supplemented with additional training or experience during work life;
Pharmaceutical or related industry work experience for 2-4 years, of which a substantial part in Computerized Systems and related functions.
Het aanbod / The offer
More information about the Data Integrity Remediation? Please contact Rob Helmich via firstname.lastname@example.org of 06-5385 38 92