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Data Integrity and eCompliance

Data Integrity and eCompliance

Germer International - Pharmaceutical RecruitingAllentown, PA, US
2 days ago
Job type
  • Full-time
Job description

Job Description

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
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