Data Integrity and eCompliance

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.

• Bachelor’s degree in Chemistry or life sciences. A minor in computer sciences is desirable.
• More than five (5) years of relevant experience.

Job Competencies.

• Excellent written and oral communication. Present and train relevant information to all levels within the company.
• Ability to adapt to and thrive in a dynamic work environment and cooperate with employees and clients from a broad range of disciplines and subject-level expertise.
• Demonstrated ability to multi-task on ongoing projects and tasks.
• To have in depth understanding of regulatory requirements and guidelines required to comply IT systems in Pharma industry – DI, Part 11, Annex 11, GAMP 5 etc.
• Knowledge of Pharma domain – Manufacturing and Quality (QA, QC)
• Experience of working on Pharma Manufacturing Site and functional knowledge about chromatography systems, SCADA, DCS etc.
• Understanding and exposure to Pharma CSV upcoming trends.
• Knowledge about Good documentation practices, DI and ALCOA
• Knowledge and experience on handling of QMS e.g. Change control, deviation and incidents.
• Knowledge and experience in equipment/facilities qualification