Hi Partners,
Good Morning.

Please help me out to submit suitable profile . Please connect with me at


*Naseer Bhat*

Desk : 609-853-0818 Ext: 2184

naseer.ah...@nityo.com

*Jr Lab Admin *



Are you looking for a change? Do you want to collaborate with some of the
best talent in the industry? Are you ready to join a company whose passion
is to provide its clients with operational excellence and helping them
optimize their needs that really make a difference to enterprises, the
community and the world? Then you are the one that we are looking for to be
part of our growing *Business IT Services (BITS) practice*, positioned
byGartner
as a leader in its first-ever Magic Quadrant for Oracle Application
Management Service Providers, Worldwide.





*Wanted: Global Innovators To Help Us Build Tomorrow’s Enterprise*

In the role of Technology Consultant, you will be a technology professional
adding value to a gamut of Software Development lifecycle stages. You will
create detailed design artifacts like program specifications, test plans;
and independently develop and review code and contribute to the go-live
plan. You will have the opportunity to collaborate with some of the best
talent in the industry to create innovative high quality and defect-free
solutions to meet our clients’ business needs.You will be part of a
learning culture, where teamwork and collaboration are encouraged,
excellence is rewarded, and diversity is respected and valued

Location for this position is Rocky Mount, NC

*Qualifications Basic*

•          Bachelor’s degree or foreign equivalent from an accredited
institution or three years of progressive experience in the specialty in
lieu of every year of education.

•          Clinical background/ knowledge and work experience in provider
set up will be an extra advantage.

•          At least 4-5 years of experience is required in healthcare
provider IT operations, consultation and diagnostic area.

•          2 years related LIMS experience: configuration, validation,
implementation, and system admin.

•          2 years’ experience in a GMP environment (preferably as a
chemist or microbiologist in a pharmaceutical lab).
2 to 3 years in computer system validation and analytical instrumentation
testing.





*Primary Skills*

•          Experience in Empower, NuGenesis, Chromeleon, or WinKQCL is
desired.  Environmental Monitoring or program design experience desired

•          Working knowledge or biology, chemistry, life sciences with
strong skills in computer system management.

•          Knowledge of cGMPs and regulatory requirements around computer
systems including 21 CFR Part 11, GAMP5, and applicable ISO standards.

•          Strong analytical skills and balanced decision making; must have
the ability to formulate appropriate system queries.

•          Possess good communication skills and attention to detail.

•          Knowledge of risk and impact assessment tools strongly desired.

•          Knowledge of root cause analysis tools and investigational
skills preferred.





*Additional Responsibilities*

•          Provides technical support for laboratory quality system to the
quality control laboratories, Biological Quality (BQ), Chemical Quality
(CQ), and Supplier Quality (SQ); Ensure that the systems comply with all
relevant regulatory standards including assessing systems for CFR Part 11
compliance/ISO Part 11 compliance.

•          Diagnostic support for application.  Management and timely
resolution of technical incidents through the standard incident and problem
management process; Responsible for elevation of incidents to 2nd tier
support and summarization and reporting of incidents to system owners and
effected users when required.

•          Ensure site on-time implementation of laboratory quality system
through support of requirements definition, functional design, management
of master data configuration, data migration, reporting design, system
validation, SOP generation, development, and end-user training.

•          Provides a key role in system governance.  Review and management
of system change control processes, including establishing or revising user
requirements, design requirements, functional specification, design
specifications, or qualification protocols.

•          Define and manage process efficiency and continuous improvement
projects for laboratory systems.

•          Technical writing for system validation protocols, standard
operating procedures, and other technical documents in support of
validation/operations.

•          Support business in creation, validation, and maintenance of
reports, calculations, and queries within quality systems.

•          Support system periodic review, security review, and audit trail
review activities.

•          Support audits and inspections to provide data and information
on request, provide ad hoc support to other department to ensure compliance
with all regulatory standards.

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