CSV Validation QC Engineer
Company: Supreme Netsoft Private Limited (SNPL)
Location: Jersey City
Posted on: April 3, 2021
Since 1995, Supremesoft Corporation has been partnering with
clients to strengthen their key business processes by identifying
critical issues and implementing innovative customized solutions.
Through the years, Supremesoft has grown steadily into a global
information technology consulting company, by establishing and
building a solid reputation on dedicated technology practices with
a highly experienced workforce. Today, many of our existing clients
turn to us as their sole trusted partner for technical expertise.--
Job Description Position Description: Mandatory Skills --- 7+ years
of Lab Systems (& lab instrumentation) validation experience is
required; with 7+ years of other CSV experience (with extensive
experience authoring requirement specs, test scripts, validation
master plans, etc)
Prefer a degree in the sciences (chemistry, biology, biochem,
--- Specific hands-on experience with validating, qualifying,
and/or using Pharmaceutical GMP QC Lab Standalone COTS systems are
--- Experience working with systems users from different sites is
required. Experience with international sites is highly
* Pharma industry experience is must
--- Excellent communication and written skills are required.
Preferred Skills --- Experience in Labware, Empower LIMS systems
--- Experience in validating Lab equipments Job
Roles/Responsibilities --- Act as Validation and Qualification Lead
on a large global GMP QC Laboratory remediation projects, with
specific focus on Laboratory Standalone COTS systems
--- Author the typical validation, qualification, and testing
documentation such as Validation Plans/Summaries, Test
Plans/Summaries, User Requirements, Configuration Specifications,
Trace Matrix, Qualification Protocols (IQ/OQ/PQ) and Scripts,
Testing Defects, etc.
--- Assist systems users with defining and documenting system use
in user, admin, and maintenance SOPs
--- Coordinate alignment of systems users from various company
sites, including international sites, on validation and
--- Proactively communicate with various company organizations and
systems vendors to ensure the project hurdles are overcome quickly
--- Provide tactical guidance and coaching in support of systems
--- Act as validation task lead: take ownership of related tasks,
work under minimal supervision, utilize the industry experience and
best judgment to make tactical decisions, stay proactive, etc.
Additional Information All your information will be kept
confidential according to EEO guidelines.
Keywords: Supreme Netsoft Private Limited (SNPL), Jersey City , CSV Validation QC Engineer, Engineering , Jersey City, New Jersey
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