QA GxP Systems Team Lead
Company: American Regent, Inc.
Posted on: February 25, 2021
The QA GxP Systems Team Lead will be responsible for generating,
reviewing and remediating computer system validation protocols for
the Chemistry and Microbiology laboratories in order to ensure that
all regulatory requirements are met. They will undertake a wide
range of duties relating to the leadership of projects. These
responsibilities will include but are not limited to: the planning,
execution, monitoring, controlling and delivery of projects. The QA
GxP Systems Team Lead will work closely with members of the GxP
team, IT, QA Compliance team and Senior Management.
-- Essential Duties and Responsibilities--
- Extensive knowledge of FDA guidelines and regulations.
- Extensive knowledge of GAMP5.
- Ability to create comprehensive status reports.
- Ability to independently manage small projects, from the
initiation phase through to deployment.
- Escalate any unresolved issues to Upper Management, and follow
through to resolution within required timelines.
- Collaborate with IT to gather infrastructure and architectural
requirements pertaining to relevant projects.
- Manage all project and compliance related issues associated
with their project.
- May support, coordinate and interface with regulatory agencies
as required in support of regulatory agency inspections.
- Support and maintain Quality programs, policies, processes,
procedures and controls ensuring compliance with current Good
Manufacturing Practices (cGMP) expectations and established agency
- Consistently perform all duties in accordance with American
Regent and Daiichi Sankyo Business Principles, corporate
directives, SOPs, policies, and government and industry regulatory
- Create and implement business continuity plans, procedures and
- Review IT Infrastructure vendor operations and outsourcing
arrangements and collaborate with major service providers of IT
- Perform infrastructure qualification activities, testing
sequences and change controls. Oversight of execution with IT team
- Collaborate with System Owner to develop Design Qualifications,
Functional Requirements, User Requirements, Unit test scripts, UAT
scripts, validation plans, validation summary report, traceability
- Develop department SOPs and provide SOP review for new
- Perform Validation/Part 11 Assessments for new and existing
- Maintain GxP Systems Inventory Log and update as
- Participate in cross-functional project teams.
- Identify and implement opportunities for continuous improvement
related to validation or other compliance practices/issues based on
internal compliance issues, industry best practices as well as
latest regulatory guidance's and regulatory updates.
- Conduct validation related training to individuals performing
various roles within validation projects.
- Participate in the development and improvement of computerized
systems to ensure quality and adherence to cGMPs. Qualifications
- Bachelor's degree and a minimum of 7+ years' experience dealing
with GxP computer systems in the pharmaceutical or similar
regulated industry. A technical background a plus.
- 2+ years' experience managing/supervisory of computer system
- Strong understanding of the current pharmaceutical industry and
computerized system regulations, including CFR Part11.
- Strong knowledge of appropriate Quality Systems and current
Good Manufacturing Practice (cGMP) requirements (FDA, EU, ICH) with
the ability to assess compliance risks.
- Experience in providing oversight in implementing and
maintaining GxP computer systems in a validated state.
- Strong working knowledge in validation methodology and software
development life cycle (SDLC)principles.
- Demonstrates ability to perform detail-oriented work with a
high degree of accuracy.
- Excellent verbal, written and interpersonal communication
- Effective time management and interpersonal skills.
- Strong organizational skills, planning skills and must work
effectively within teams.
- Strong analytical problem solving skills.
- Ability to resolve conflicts and disputes on regulatory
- Ability to perform limited travel both domestically and
internationally. American Regent celebrates diversity and we are
committed to creating an inclusive environment for all employees.
We are an Equal Opportunity Employer and all qualified applicants
will receive consideration for employment without regard to race,
color, religion, sex, national origin, disability status, protected
veteran status, or any other characteristic protected by law.
Posted 7 Days Ago Full time R-100373 About Us Our values define who
we are. They are the fundamental beliefs of our organization and
guide our actions and behavior. They influence the way we work with
each other, the way we serve our clients, and the way we engage
with our communities. Supporting patient health and enhancing the
quality of life for animals are our guiding principles. Our promise
is to provide the healthcare marketplace with a steady supply and
broad portfolio of branded and generic specialty injectables.
American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10
injectable manufacturer. For over 50 years, we have been
developing, manufacturing, and supplying high-quality generic and
branded injectables for healthcare providers and veterinarians
across the United States and Canada. For 20 years, American Regent
has been a leader in IV iron therapy and we supply two of the
top-selling brands in the US today. For over 30 years, we have
supplied the leading joint health products for horses and dogs. We
have locations in New York, Ohio, and Pennsylvania and sales
Keywords: American Regent, Inc., Stamford , QA GxP Systems Team Lead, Other , Shirley, Connecticut
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