Quality Specialist, Date Integrity, OeC
Company: Kelly Services
Posted on: September 24, 2022
Kelly Services is actively recruiting for a Quality Specialist,
Data Integrity, QeC for a Direct Hire opportunity in the Greater
Detroit area, MI. Customer Job Title: Quality Specialist, Date
Integrity, QeCJob Description: 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. To perform this position
successfully, an individual must be able to perform each essential
duty satisfactorily. The requirements listed below are
representative of the knowledge, skill and/or ability required:
--- 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 the Client's mission,
vision, and values.
--- Identify and protect the original technical information as part
of the company property. 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
--- 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
--- 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
--- 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
--- Guide and mentor site teams on compliance of IT and electronic
--- Stay up to date on advances in the software and technology;
provide appropriate training to new and current employees as
--- Bachelor's degree in Chemistry or life sciences. A minor in
computer sciences is desirable.
--- More than five (5) years of relevant experience. JOB
--- 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
--- 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,
--- Experience of working on Pharma Manufacturing Site and
functional knowledge about chromatography systems, SCADA, DCS
--- 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
JOB CONDITIONS. The physical demands and work environment described
here are representative of those that must be met by a team member
to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with
disabilities to perform the essential functions.
--- Physical Demands: o Frequent lifting, bending, stooping,
squatting, pushing and pulling can be expected. o Long periods of
standing and walking can be expected in this position. o This
position may require long periods of sitting, typing, computer
entry or looking at a computer.
If you feel you have the knowledge and expertise, apply today to
connect with a Kelly professional who will work to enrich your
Keywords: Kelly Services, Detroit , Quality Specialist, Date Integrity, OeC, Other , Riverview, Michigan
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