Company: Zifo
Technologies, Inc.
Location: 245
Main St. Floor 4, Cambridge MA 02142
Position Title: GxP
Consultants
Job
Description:
Formulate
opinions based on broader industry trends, regulatory requirements and help
clients maintain quality application in a GxP state. Perform GxP consulting
including Good Laboratory Practices, Good Clinical Practices, and Good
Manufacturing Practices. Responsible for implementation and computer System
Validation. Meet with stakeholders to understand capability needs, bottlenecks
and business priorities. Review the application requirements and determine the
GxP needs. Perform risk assessments and regulatory assessments. Work with
development and vendor teams to establish the required compliance requirements
on the application. Provide inputs on regulatory and quality questions. Engage
with Industry Experts and leaders to understand Industry Focus and direction
for the future. Understand Industry Regulations and Compliance Requirements
from regulatory agencies such as FDA. Develop risk-based validation and
regulatory approach to accelerate the drug development and medical device
development process. Participate and present in webinars and conferences on
Regulatory and Quality. Review the system development process and prepared Risk
Assessments, Regulatory Assessments and GxP Assessments. Develop Regulatory and
Validation strategy to qualify the application and create the required
validation package. Create installation, operational and performance
qualification scripts. Establish traceability between the system and regulatory
requirements against the qualification scripts. Perform validation testing and
create validation summary reports. Create project charter. Define SDLC
Methodology (e.g., Waterfall, Agile). Develop change management and risk
management strategies. Manage stakeholders and resolve conflicts. Conduct
status meetings and status reports. Coordinate with global delivery and
validation team from Zifo for validation testing and documentation. Travel and
work at client sites as assigned. Anticipated 25% domestic travel. Multiple
Positions Available.
Job
Requirements:
Requires
a Bachelor’s degree, or foreign equivalent, in Life Sciences, Biotechnology,
Information Systems or a related field plus two (2) years of experience in the
job offered or a related role. Alternatively, the employer will accept four (4)
years of work experience in a related field in lieu of a Bachelors plus two (2)
years of described experience.
Requires
two (2) years of experience in the following:
·
Research & Development in clinical and manufacturing areas of
pharmaceutical industry.
·
Regulatory Consulting, GxP Consulting and Quality area.
Required
two (2) years of experience in the following:
·
Project management and solution implementation.
·
At least one (1) of the following: Drug Development functions, Clinical,
or GMP
·
Waterfall and Agile.
·
Software Testing and Computer System Validation.
·
Regulatory knowledge on 21 CFR part 11, part 58 (GLP), 210 and 11
(GMP), 820 (Quality System Regulations).
·
Risk management techniques such as FMEA, 5 WHYs or similar.
·
Office Productivity Tools such as MS Word, Excel, PowerPoint, or Similar
office productivity tools.
·
At least one (1) of the following tools: EDC systems, CTMS systems, LIMS
systems, ELN platforms, Quality and Document Management Systems or Analytical
Instruments utilized in manufacturing and quality control laboratories.
Travel
and work at client sites as assigned. Anticipated 25% domestic travel.
$107,000 – $110,000
Qualified
applicants please: Email resume, referencing [ZT034], including job history,
to: Zifo-US-HR@zifornd.com.
