I am currently working with globally and diverse teams to provide compliance expertise for Pharmacovigilance, Commercial, ERP, Data & Analytics Computerized systems my main responsibilities and tasks are:- Assist and work closely with the system project team for planning and execution activities.- Support system project team through the day to day activities or base business activities - Create a collaborative environment with the business process teams to challenge current… Show more I am currently working with globally and diverse teams to provide compliance expertise for Pharmacovigilance, Commercial, ERP, Data & Analytics Computerized systems my main responsibilities and tasks are:- Assist and work closely with the system project team for planning and execution activities.- Support system project team through the day to day activities or base business activities - Create a collaborative environment with the business process teams to challenge current processes and propose improvement to the quality systems in to address potential risks.- Responsible for reviewing and approving validation deliverables of GxP regulated Computerized systems to ensure full compliance with Health Authority regulatory requirements and adherence to company policies and procedures by supporting CSV projects and base business support.- Ensure Inspection readiness of GxP systems to minimize compliance and risks potential audit observations.- Provide support to internal and external health regulatory audits.- Define actions and Support Business team to address audit non-conformities.- Suggest and implement actions to improve current procedures and reduce compliance risks.- Responsible for the review and approval of SDLC validation documentation deliverables including the approval to release system implementation or changes for production use.- Provide CSV guidance to business stakeholders in the resolution of validation documentation corrections or test defects. Show less

Responsibilities and task:- Act as a primary contact person between the system project team and quality department.- Determine regulations that are applicable to computerized system and need for validation.- Provide support, guidance and advice with regard to computerized system validation and IT infrastructure within GxP area and 21 CFR Part 11.- Provide assurance that GxP regulated computerized systems are suitably implemented and managed in accordance with Actelion… Show more Responsibilities and task:- Act as a primary contact person between the system project team and quality department.- Determine regulations that are applicable to computerized system and need for validation.- Provide support, guidance and advice with regard to computerized system validation and IT infrastructure within GxP area and 21 CFR Part 11.- Provide assurance that GxP regulated computerized systems are suitably implemented and managed in accordance with Actelion requirements and regulatory requirements.- Perform quality review and/or create validation documents required by internal procedures.- Lead and Participate in multiple internal and supplier audit including follow up of the audit observations regarding IT activities and computerized system validation.- Administration of the internal inventory system (Sycomor) encompassing user management and training, implementation and testing of changes.Additional Responsibilities and task as of September 2018:Support the integration of Actelion's computerized system into the J&J validation framework, including:- Assist closing compliance gaps identified during post acquisition audit- Support migration of IT Infrastructure from Actelion to J&J datacenter- Provide quality review for the retirement of Validated computerized system and archiving of GxP records.- Assure compliance of the legacy Actelion computerized systems with J&J SDLC. Show less

Administration of the internal inventory system (Sycomor): user management and training, change and configuration management, contact with the vendor to coordinate the implementation of new features, update of the validation documentation (URS, FS test scripts).