Data Integrity and eCompliance (Allentown)

Data Integrity and eCompliance Specialist

Key responsibilities.

• Data Integrity Compliance Officer (DICO), lead gap assessments of new and existing systems / practices; perform DI risk assessments for identified gaps; perform DI Audits of site; provide timely update on DI plan to Central DICO; and ensure site team is trained on DI aspects and requirements.
• To define validation strategy and review CSV deliverables for Site IT projects e.g. URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk assessment, etc. for applications installed at Riverview Site.
• To define equipment / facilities qualification strategy and review Validation Department deliverables for Site equipment / facilities qualification e.g. URS, FRS, IQ, OQ, PQ, Risk assessment, drawings etc. for equipment / facilities at Riverview Site.
• To have thorough understanding, practical approaches for Computer system validation (CSV) of applications.
• Author, review and approval of SOPs, Guidelines / Policies as applicable to CSV, DI and equipment / facilities qualification.
• To perform periodic and audit trail review of computerized systems as per defined frequency.
• To support the initiatives undertaken by Corporate Quality eCompliance team in Riverview Site.
• Ability to represent during regulatory audits.
• Accountable to ensure compliance of CSV documentation and qualification during various phases (project, operational & retirement) of software lifecycle (SLC) and equipment / facilities.
• Well aware with GAMP5, CFR Part 11 / EU Annex 11, Data integrity and ICH Q7 requirements.
• To ensure infrastructure (Network, Servers, Cloud, Database)and equipment / facilities are qualified as per required Quality standards and required documents are in place.
• To review QMS documents e.g. Change control / Deviation / Incidents-Discrepancy / User access forms
• To review and approve Root cause analysis and CAPA based on QMS documents.
• To guide and train Site IT & Business teams at Site for CSV, Data Integrity and Regulatory Compliance activities.
• To work along with CSV, Engineering & Project Manager to ensure project timelines are met.
• Review, approve and ensure compliance of the implementation, maintenance, and update of existing drawings from as-designed to as-built as appropriate for equipment / facilities.
• Ensure compliance and review / approve of site Validation Master Plan to include all GMP systems used at the site, including schedules for periodic review and as required, equipment / system requalification.
• Guide and mentor site teams on compliance of IT and electronic systems.
• Stay up to date on advances in the software and technology; provide appropriate training to new and current employees as needed.

Qualifications

EDUCATION / EXPERIENCE.

Job Competencies.