Quality Specialist - Data Integrity and QeC

8/18/22

Riverview, MI

1799

1799 Quality Specialist - Data Integrity and QeC

POSITION SUMMARY: Quality Specialist - Data Integrity and QeC is responsible for the administration and coordination of the sites’ Data Integrity compliance, QeC and equipment/facilities qualification review and approval to meet end-user needs and regulatory expectations (21 CFR Part 11 and cGMP), and established SOP’s.

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 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.

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.

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