Hi Folks,
Please share the suitable resource for this Position.
Please share the Visa Copy and Photo ID Proof of your consultants. at
*manish.gu...@nityo.com
<manish.gu...@nityo.com>*
=================================================================
*Urgent Requirement: Validation Consultant (OH)*

*Role : Validation Consultant/ Project Quality Engineer*

*Work Location : Cincinnati, OH*

*Duration of assignment (in Months) : 12 months*

*Relevant Experience(in Yrs) : 5-10 Years*



*Technical /Functional Skills*

The Supplier Quality Engineer should excel in an environment that embraces
teamwork, change, risk-based decision-making and flexibility.



He should also be able to:

•             Perform supplier evaluation and qualification

•             Analyze validation test data to determine whether systems or
processes have met validation criteria or to identify root causes of
production problems.

•             Develop validation master plans, process flow diagrams, test
cases, or standard operating procedures.

•             Prepare, maintain, or review validation and compliance
documentation, such as engineering change notices, schematics, or protocols.

•             Conduct validation or qualification tests of new or existing
processes, equipment, or software in accordance with internal protocols or
external standards.

•             Conduct Designs validation study features, such as sampling,
testing, or analytical methodologies.

•             Develop project plans for Validation/Qualification projects

•             Write master plans relating to any specified projects and
conduct meetings to execute the validation plan.

•             Direct validation activities, such as protocol creation or
testing.

•             Prepare validation or performance qualification protocols for
new or modified manufacturing processes, systems, or equipment.

•             Adhere to all customer/company and GMP procedures, along with
safety regulations within the workplace.



*Experience Required*

•             A minimum of 5 years’ experience in a highly regulated
industry is required. Medical Device and/or Pharmaceutical industry is
preferred.

•             Experience in supplier evaluation and qualification

•             Strong knowledge of Advanced Product Quality Planning (APQP),

Production Part Approval Process (PPAP), Failure Mode and Effect Analysis
(FMEA)

•             Lean Manufacturing knowledge

•             Understanding supplier manufacturing processes

•             Ability to work in a diverse and dynamic environment

•             Planning and prioritising activities

•             Good communication and interpersonal skills

•             Experience in interpreting graphs, charts, engineering
diagrams, blueprints, shop orders, equipment guides and other instructions
to solve problems.

•             Experience writing Functional Requirements, Design
Specifications, FAT’s, SAT’s, IQ’s, OQ’s, PQ’s.

•             Experience executing FAT’s, SAT’s, receipt verification, IQ,
OQ, PQ.

•             Experience using scientific rules and methods to solve
problems.

•             Experience in identifying complex problems and developing and
evaluating options and implementation of solutions.

•             Should have knowledge of Process and Product Validation
requirements and techniques.

•             Excellent problem solving and decision-making skills will be
required. Interpersonal skills that foster conflict resolution as it
relates to technical situations will be required.

•             Process validation experience is required.



*Roles & Responsibilities*

*•             Authoring and approving IQ/OQ/PQ document*

*•             Authoring and approving engineering study*

*•             Authoring and approving test methods*

*•             Supplier evaluation and qualification*

•             Execute & report all validation activities including analysis
(DQ / IQ / OQ / PQ / PPQ / PFMEA)

•             Work with Engineering (Design and Manufacturing Engineers)
team to define process parameters and criteria to ensure supplier process
capability is effective to meet product and process requirements

•             Facilitate root cause analysis and corrective actions of
supplier quality issues

•             Collate and evaluate supplier quality data to identify
process improvement opportunities within the supply

•             Work with the supplier directly, create correction action
plans to address process failures

•             Review supplier manufacturing processes, collaborate with
suppliers on process improvement and value enhancement opportunities

•             Participate in cross-functional teams in the development of
new products or changes related to current products in meeting customer
requirements

•             Support and lead process improvement activities at the
supplier place.

•             Review and provide solution for rejection and prepare QC and
production report.

•             Prepares, maintains, or reviews validation and compliance
documentation, such as engineering change notices, schematics, or protocols.

•             Ensure compliance to the laid down quality system
requirements and ISO 13485 standards.

•             Studies product characteristics or customer requirements and
confer with management to determine validation objectives and standards.

•             Directs validation activities, such as protocol creation or
testing.

•             Prepares validation or performance qualification protocols
for new or modified manufacturing processes, systems, or equipment.

•             Work with other teams/departments to ensure the proper
application of design controls, risk management and the
investigation/correction of design failures/challenges



*Generic Managerial Skills*

Supplier Quality Engineer will assume the role of team leader and organize
QA and other departments to achieve the successful introduction of new
products, including:

•             Handling several projects concurrently

•             Meet delivery promise in terms of budget and timescales.

•             Work within a multi-discipline team, consisting of the R&D
Development Group, Marketing, Quality, Operations, etc.


*Urgent Requirement: Linux Firmware Developer (MN)*

*Role : Linux Firmware Developer*

*Work Location : Minneapolis, MN*

*Duration of assignment (in Months) : 6-12 months*



*Description:*

•             Strong expertise/experience in Linux package management/tools
setup

•             kernel debugging

•             driver development

•             Application development.

Thanks & Regards!
*Manish Gupta*
*Desk : **609-853-0818 **Ext. 2130*
*Email : manish.gu...@nityo.com <manish.gu...@nityo.com>*

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