QA – Quality Specialist, Data Integrity & QeC

QA Specialist


Hours: M-F/ 8am- 5pm

Pay: 100K

Quality Specialist – Data Integrity and QeC is responsible for administrating and coordinating 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:

  • Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, ICH, and related safety, health, and environmental procedures, policies, and practices.
  • Consistent support and practice of all company missions, vision, and values.
  • Identify and protect the original technical information as part of the company property.
  • 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.
  • Aware of GAMP5, CFR Part 11/EU Annex 11, Data integrity and ICH Q7 requirements.
  • Ensure infrastructure (Network, Servers, Cloud, Database) and equipment/facilities are qualified as per required Quality standards and required documents are in place.
  • 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.



  • Bachelor’s degree in life sciences (minor in computer science is a plus)
  • Minimum of 5 years of experience working in a Quality/ GMP environment
  • Experience in the Pharmaceutical industry
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