Urgent Requirement for Validation Analyst ---- { Passport No. Required } ----

[harish karnala]

Hi

Hope you are doing well !!   

My name is  *Harish Karnala* and I am a 
*technical 
recruiter* with *United Software group*. I reviewed your information online 
and I am impressed with your qualifications. One of my clients in the *Peapack, 
NJ* Area currently has *Validation Analyst*  that they are looking to fill. 
Here are the details on the role.

 

*JD:*

 

1. 5 Day at site - Peapack, NJ (Must, no 2-3 days) 

2. Pharma Exp. (Must – 5+ years)

3. Computer System Validation (CSV +5 years)

4. Should have knowledge of 21 CFR Part 11 - ERES (GxP)

5. HP ALM Experience (Must – 2+ years)

6. GAMP 5 knowledge

7. Good System testing exp (Must – 5+ years)

8. Good Communication

9. Business Analyst experience (Good to have)

 

· 6 – 8 years of experience in testing domain.

· 4 to 6 years as Validation Analyst.

· Documenting functional and integration requirements

· Creation (or change of existing) test script documents

· Test script updates, configuration changes and related testing 

· Final Verification testing

· Creation of all supporting documentation: technical design, 
installation documents, integration deployment documents, interface mapping 
documents

· Strengths should include functional knowledge of various testing 
types & technologies, client interactions, handling teams, project planning 
and co-ordination of team in varied geographies.

· Excellent oral and written communication as well as analytical 
and interpersonal skills.

· Experience in working with clients from various backgrounds and 
at various geographical locations.

· Expertise in QA, Requirement Analysis, Team Management, Planning, 
Estimations, Scheduling, and Defect Management (using ALM-QC).

· Should have experience on Test Planning, Testing Effort 
Estimation and Test strategy creation.

· Ensure compliance of all testing artifacts and processes

· Coordination with stakeholders, BA, testing team and Quality team.

· Provide status to program team on testing activities of on-going 
applications

· Reviews and root cause analysis of testing activities.

· Experience within a delivery role

· Experience with client facing consulting engagements.

· Knowledge of Pharma domain.

· Working knowledge of performance testing and tools

· HP Quality Center /ALM; MS Dynamics

· Should be well versed with the Pharma domain – terminology & 
industry standards.

· Should have knowledge of 21 CFR Part 11– Computer Systems 
Validation and other compliance processes.

Harish Karnala

United Software Group Inc.. 

565 Metro Place South. Suite # 110 


Dublin, OH 43017 

 

Direct Number : +1 614-408 1549

Board Number : 614-495-9222 EXT. 622

Fax: 1-866-764-1148

 

karnal...@usgrpinc.com 

Hangouts: harirecruite...@gmail.com

www.usgrpinc.com

 

 

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Urgent Requirement for Validation Analyst --- { Passport No. Required } ----

[harish karnala]

Hi

Hope you are doing well !!   

My name is  *Harish Karnala* and I am a 
*technical 
recruiter* with *United Software group*. I reviewed your information online 
and I am impressed with your qualifications. One of my clients in the  
*Peapack, 
NJ* area currently has *Validation Analyst  *that they are looking to fill. 
Here are the details on the role.

 

*JD:*

 

*Job Title*

Validation Analyst

*Relevant Experience  & Experience Required*

*(in Yrs)*

· 4 to 6 years as validation Analyst

· HP ALM hands-on experience

· Pharma experience is required

· GAMP 5 knowledge

*Key words to search in resume*

Validation Analyst, Computer System Validation 

*Technical/Functional Skills**   -MUST HAVE SKILLS*

· 5 Day at client site - Peapack, NJ 

· *Pharma Experience (Must have – 5+ years)*

· Computer System Validation (Must have +5 years)

· Excellent knowledge of *21 CFR Part 11 - ERES (GxP) (Must have)*

· HP ALM Experience (Must have – 2+ years)

· GAMP 5 knowledge (Must have)

· Good System testing experience (Must have – 5+ years)

· Good Communication

· Business Analyst experience (Good to have) 

*Roles & Responsibilities*

· Documenting functional and integration requirements

· Creation (or change of existing) test script documents

· Test script updates, configuration changes and related testing 

· Final Verification testing

· Creation of all supporting documentation: technical design, 
installation documents, integration deployment documents, interface mapping 
documents

· Strengths should include functional knowledge of various testing 
types & technologies, client interactions, handling teams, project planning 
and co-ordination of team in varied geographies.

· Excellent oral and written communication as well as analytical 
and interpersonal skills.

· Experience in working with clients from various backgrounds and 
at various geographical locations.

· Expertise in QA, Requirement Analysis, Team Management, Planning, 
Estimations, Scheduling, and Defect Management (using ALM-QC).

· Should have experience on Test Planning, Testing Effort 
Estimation and Test strategy creation.

· Ensure compliance of all testing artifacts and processes

· Coordination with stakeholders, BA, testing team and Quality team.

· Provide status to program team on testing activities of on-going 
applications

· Reviews and root cause analysis of testing activities.

· Experience within a delivery role

· Experience with client facing consulting engagements.

· Knowledge of Pharma domain.

· Working knowledge of performance testing and tools

· HP Quality Center /ALM; MS Dynamics

· Should be well versed with the Pharma domain – terminology & 
industry standards.

· Should have knowledge of 21 CFR Part 11– Computer Systems 
Validation and other compliance processes.

*Duration of assignment *(in Months)

12 months

*Work Location *(State, City )

Peapack, NJ

 

 

Harish Karnala

United Software Group Inc.. 

565 Metro Place South. Suite # 110 


Dublin, OH 43017 

 

Direct Number : +1 614-408 1549

Board Number : 614-495-9222 EXT. 622

Fax: 1-866-764-1148

 

karnal...@usgrpinc.com 

Hangouts: harirecruite...@gmail.com

www.usgrpinc.com

 

 

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Urgent Requirement for Validation Analyst --- { NO OPT'S And Passport No. Required } ---

[harish karnala]

Hi,

Hope you are doing well !!   

My name is  *Harish Karnala* and I am a 
*technical 
recruiter* with *United Software group*. I reviewed your information online 
and I am impressed with your qualifications. One of my clients in the  
*Allendale, 
NJ*  area currently has a *Validation Analyst* role that they are looking 
to fill. Here are the details on the role.

 

 

*JD:  *

 

*Job Title*

Validation Analyst

*Relevant Experience* 

*(in Yrs)*

6 to 8 Years

*Technical/Functional Skills* 

· Experience in Validation Engineering in FDA regulated 
Pharmaceutical environment with concentration in Computer System Validation 
(CSV)

· Design of Validation documents like Validation plan, IQ/OQ/PQ 
Protocols, Test cases and Traceability Matrix, Summary reports.

· Knowledge of FDA 21 CFR Part 11, 50, 58, 210, 211, 312, 314 and 
820 and general principles of Software Validation Life Cycle.

· Familiarity of TrakSYS application, Infrastructure Validation is 
a plus

· GDPR basic Knowledge 

*Experience Required*

Computer Systems, and Software QA Engineer /Experience in Validation 
Engineering in FDA regulated Pharmaceutical environment with concentration 
in Computer System Validation (CSV)

*Roles & Responsibilities*

· Ensures documentation and practices meet quality standards, 
applicable regulatory compliance and IS guidelines/policies

· Review functional design specification, technical design 
specifications for clarity, Good documentation practices.

· Review the accuracy and completeness of software validation 
deliverables created by process work streams 

· Perform Validation and Qualification of GXP/Non GXP, 
Infrastructure and Branch Moves

· Write and execute Computer System Validation (CSV) Protocols and 
Validation Summary Reports

· Perform Validation of Manufacturing Execution Systems software 
(TrakSYS) – Good to have

*Generic Managerial Skills*

Good Communication skill

Ability to connect to various teams

Self-motivated and proper status reporting, highlighting risks/challenges 
etc

Familiar with Offshore model and Good team interaction

*Education*

4 year Degree in Computer Science, Information Systems, or equivalent is 
preferred

*Duration of assignment *(in Months)

6 months – extendable to 1 year

*Work Location* 

Allendale, NJ, USA

 

 

Harish Karnala

United Software Group Inc.. 

565 Metro Place South. Suite # 110 


Dublin, OH 43017 

 

Direct Number : +1 614-408 1549

Board Number : 614-495-9222 EXT. 622

Fax: 1-866-764-1148

 

karnal...@usgrpinc.com 

Hangouts: harirecruite...@gmail.com

www.usgrpinc.com

 

 

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Urgent Requirement for Validation Analyst --- { Passport No. Required } --

[harish karnala]

Hi,

Hope you are doing well !!   

My name is  Harish Karnala and I am a 
technical recruiter with United Software group. I reviewed your information 
online and I am impressed with your qualifications. One of my clients in 
the Peapack, NJ  area currently has a Validation Analyst role that they are 
looking to fill. Here are the details on the role:  

JD:

 

*Job Title* 

Validation Analyst 

*Relevant Experience  & Experience Required* 
*(in Yrs)* 

·6-8 years of experience in testing domain. 
·4 to 6 years as validation Analyst 
·HP ALM hands-on experience 
·Pharma experience is required 
·GAMP 5 knowledge 

*Key words to search in resume* 

Validation Analyst, Computer System Validation 

*Technical/Functional Skills   -MUST HAVE SKILLS* 

·6 – 8 years of experience in testing domain. 
·4 to 6 years as Validation Analyst 
·Documenting functional and integration requirements 
·Creation (or change of existing) test script documents 
·Test script updates, configuration changes and related testing 
·Final Verification testing 
·Creation of all supporting documentation: technical design, 
installation documents, integration deployment documents, interface mapping 
documents 
·Strengths should include functional knowledge of various testing 
types & technologies, client interactions, handling teams, project planning 
and co-ordination of team in varied geographies. 
·Excellent oral and written communication as well as analytical and 
interpersonal skills. 
·Experience in working with clients from various backgrounds and at 
various geographical locations. 
·Expertise in QA, Requirement Analysis, Team Management, Planning, 
Estimations, Scheduling, and Defect Management (using ALM-QC). 
·Should have experience on Test Planning, Testing Effort Estimation 
and Test strategy creation. 
·Ensure compliance of all testing artifacts and processes 
·Coordination with stakeholders, BA, testing team and Quality team. 
·Provide status to program team on testing activities of on-going 
applications 
·Reviews and root cause analysis of testing activities. 
·Experience within a delivery role 
·Experience with client facing consulting engagements. 
·Knowledge of Pharma domain. 
·Working knowledge of performance testing and tools 
·HP Quality Center /ALM; MS Dynamics 
·Should be well versed with the Pharma domain – terminology & 
industry standards. 
·Should have knowledge of 21 CFR Part 11– Computer Systems 
Validation and other compliance processes. 

*Roles & Responsibilities* 

·6 – 8 years of experience in testing domain. 
·4 to 6 years as Validation Analyst 
·Documenting functional and integration requirements 
·Creation (or change of existing) test script documents 
·Test script updates, configuration changes and related testing 
·Final Verification testing 
·Creation of all supporting documentation: technical design, 
installation documents, integration deployment documents, interface mapping 
documents 
·Strengths should include functional knowledge of various testing 
types & technologies, client interactions, handling teams, project planning 
and co-ordination of team in varied geographies. 
·Excellent oral and written communication as well as analytical and 
interpersonal skills. 
·Experience in working with clients from various backgrounds and at 
various geographical locations. 
·Expertise in QA, Requirement Analysis, Team Management, Planning, 
Estimations, Scheduling, and Defect Management (using ALM-QC). 
·Should have experience on Test Planning, Testing Effort Estimation 
and Test strategy creation. 
·Ensure compliance of all testing artifacts and processes 
·Coordination with stakeholders, BA, testing team and Quality team. 
·Provide status to program team on testing activities of on-going 
applications 
·Reviews and root cause analysis of testing activities. 
·Experience within a delivery role 
·Experience with client facing consulting engagements. 
·Knowledge of Pharma domain. 
·Working knowledge of performance testing and tools 
·HP Quality Center /ALM; MS Dynamics 
·Should be well versed with the Pharma domain – terminology & 
industry standards. 
·Should have knowledge of 21 CFR Part 11– Computer Systems 
Validation and other compliance processes. 

*Duration of assignment *(in Months) 

12 months 

*Work Location *(State, City ) 

Peapack, NJ

 

 

 

Harish Karnala

United Software Group Inc.. 

565 Metro Place South. Suite # 110 

Urgent Requirement for Validation Analyst --- { Passport No. Required } ---

[harish karnala]

Hi,

Hope you are doing well !!   

My name is  Harish Karnala and I am a 
technical recruiter with United Software group. I reviewed your information 
online and I am impressed with your qualifications. One of my clients in 
the Peapack, NJ  area currently has a Validation Analyst role that they are 
looking to fill. Here are the details on the role:  

 

JD:

 

*Job Title* 

Validation Analyst 

*Relevant Experience  & Experience Required* 
*(in Yrs)* 

·6-8 years of experience in testing domain. 
·4 to 6 years as validation Analyst 
·HP ALM hands-on experience 
·Pharma experience is required 
·GAMP 5 knowledge 

*Key words to search in resume* 

Validation Analyst, Computer System Validation 

*Technical/Functional Skills   -MUST HAVE SKILLS* 

·6 – 8 years of experience in testing domain. 
·4 to 6 years as Validation Analyst 
·Documenting functional and integration requirements 
·Creation (or change of existing) test script documents 
·Test script updates, configuration changes and related testing 
·Final Verification testing 
·Creation of all supporting documentation: technical design, 
installation documents, integration deployment documents, interface mapping 
documents 
·Strengths should include functional knowledge of various testing 
types & technologies, client interactions, handling teams, project planning 
and co-ordination of team in varied geographies. 
·Excellent oral and written communication as well as analytical and 
interpersonal skills. 
·Experience in working with clients from various backgrounds and at 
various geographical locations. 
·Expertise in QA, Requirement Analysis, Team Management, Planning, 
Estimations, Scheduling, and Defect Management (using ALM-QC). 
·Should have experience on Test Planning, Testing Effort Estimation 
and Test strategy creation. 
·Ensure compliance of all testing artifacts and processes 
·Coordination with stakeholders, BA, testing team and Quality team. 
·Provide status to program team on testing activities of on-going 
applications 
·Reviews and root cause analysis of testing activities. 
·Experience within a delivery role 
·Experience with client facing consulting engagements. 
·Knowledge of Pharma domain. 
·Working knowledge of performance testing and tools 
·HP Quality Center /ALM; MS Dynamics 
·Should be well versed with the Pharma domain – terminology & 
industry standards. 
·Should have knowledge of 21 CFR Part 11– Computer Systems 
Validation and other compliance processes. 

*Roles & Responsibilities* 

·6 – 8 years of experience in testing domain. 
·4 to 6 years as Validation Analyst 
·Documenting functional and integration requirements 
·Creation (or change of existing) test script documents 
·Test script updates, configuration changes and related testing 
·Final Verification testing 
·Creation of all supporting documentation: technical design, 
installation documents, integration deployment documents, interface mapping 
documents 
·Strengths should include functional knowledge of various testing 
types & technologies, client interactions, handling teams, project planning 
and co-ordination of team in varied geographies. 
·Excellent oral and written communication as well as analytical and 
interpersonal skills. 
·Experience in working with clients from various backgrounds and at 
various geographical locations. 
·Expertise in QA, Requirement Analysis, Team Management, Planning, 
Estimations, Scheduling, and Defect Management (using ALM-QC). 
·Should have experience on Test Planning, Testing Effort Estimation 
and Test strategy creation. 
·Ensure compliance of all testing artifacts and processes 
·Coordination with stakeholders, BA, testing team and Quality team. 
·Provide status to program team on testing activities of on-going 
applications 
·Reviews and root cause analysis of testing activities. 
·Experience within a delivery role 
·Experience with client facing consulting engagements. 
·Knowledge of Pharma domain. 
·Working knowledge of performance testing and tools 
·HP Quality Center /ALM; MS Dynamics 
·Should be well versed with the Pharma domain – terminology & 
industry standards. 
·Should have knowledge of 21 CFR Part 11– Computer Systems 
Validation and other compliance processes. 

*Duration of assignment *(in Months) 

12 months 

*Work Location *(State, City ) 

Peapack, NJ

 

 

 

Harish Karnala

United Software Group Inc.. 

565 Metro Place South. Suite # 110 

Urgent Requirement for Validation Analyst -- { Passport No. Required } ---

[harish karnala]

Hi,

Hope you are doing well !!   

  This is Harish From USG.I 
have an Urgent Requirement for Validation Analyst. I hope your resume fits 
for the below position. Kindly let me know your interest and also required 
your updated resume. Please feel free to reach me any time.

   

   

*Job Title* 

Validation Analyst 

*Relevant Experience  & Experience Required* 
*(in Yrs)* 

·6-8 years of experience in testing domain. 
·4 to 6 years as validation Analyst 
·HP ALM hands-on experience 
·Pharma experience is required 
·GAMP 5 knowledge 

 

*Technical/Functional Skills   -MUST HAVE SKILLS* 

·6 – 8 years of experience in testing domain. 
·4 to 6 years as Validation Analyst 
·Documenting functional and integration requirements 
·Creation (or change of existing) test script documents 
·Test script updates, configuration changes and related testing 
·Final Verification testing 
·Creation of all supporting documentation: technical design, 
installation documents, integration deployment documents, interface mapping 
documents 
·Strengths should include functional knowledge of various testing 
types & technologies, client interactions, handling teams, project planning 
and co-ordination of team in varied geographies. 
·Excellent oral and written communication as well as analytical and 
interpersonal skills. 
·Experience in working with clients from various backgrounds and at 
various geographical locations. 
·Expertise in QA, Requirement Analysis, Team Management, Planning, 
Estimations, Scheduling, and Defect Management (using ALM-QC). 
·Should have experience on Test Planning, Testing Effort Estimation 
and Test strategy creation. 
·Ensure compliance of all testing artifacts and processes 
·Coordination with stakeholders, BA, testing team and Quality team. 
·Provide status to program team on testing activities of on-going 
applications 
·Reviews and root cause analysis of testing activities. 
·Experience within a delivery role 
·Experience with client facing consulting engagements. 
·Knowledge of Pharma domain. 
·Working knowledge of performance testing and tools 
·HP Quality Center /ALM; MS Dynamics 
·Should be well versed with the Pharma domain – terminology & 
industry standards. 
·Should have knowledge of 21 CFR Part 11– Computer Systems 
Validation and other compliance processes. 

*Roles & Responsibilities* 

·6 – 8 years of experience in testing domain. 
·4 to 6 years as Validation Analyst 
·Documenting functional and integration requirements 
·Creation (or change of existing) test script documents 
·Test script updates, configuration changes and related testing 
·Final Verification testing 
·Creation of all supporting documentation: technical design, 
installation documents, integration deployment documents, interface mapping 
documents 
·Strengths should include functional knowledge of various testing 
types & technologies, client interactions, handling teams, project planning 
and co-ordination of team in varied geographies. 
·Excellent oral and written communication as well as analytical and 
interpersonal skills. 
·Experience in working with clients from various backgrounds and at 
various geographical locations. 
·Expertise in QA, Requirement Analysis, Team Management, Planning, 
Estimations, Scheduling, and Defect Management (using ALM-QC). 
·Should have experience on Test Planning, Testing Effort Estimation 
and Test strategy creation. 
·Ensure compliance of all testing artifacts and processes 
·Coordination with stakeholders, BA, testing team and Quality team. 
·Provide status to program team on testing activities of on-going 
applications 
·Reviews and root cause analysis of testing activities. 
·Experience within a delivery role 
·Experience with client facing consulting engagements. 
·Knowledge of Pharma domain. 
·Working knowledge of performance testing and tools 
·HP Quality Center /ALM; MS Dynamics 
·Should be well versed with the Pharma domain – terminology & 
industry standards. 
·Should have knowledge of 21 CFR Part 11– Computer Systems 
Validation and other compliance processes. 

 

 

*Duration of assignment *(in Months) 

12 months 

*Work Location *(State, City ) 

Peapack, NJ

 

 

Harish Karnala

United Software Group Inc.. 

565 Metro Place South. Suite # 110 
<https://maps.google.com/?q=565+Metro+Place+S

Urgent Requirement for Validation Analyst

[harish karnala]

 

Hi

Hope you are doing well !!



  This is Harish From USG.I 
have an Urgent Requirement for Validation Analyst. I hope your resume fits 
for the below position. Kindly let me know your interest and also required 
your updated resume. Please feel free to reach me any time.






*Role *:Validation Analyst

*Location* : Allendale NJ

*Duration* : 6 months 

*Experience: *6 Years +


 


*JD*

 

*Technical/Functional Skills* 

 

Software Validation, Pharma

 

*Experience Required *

•Working experience in Validation projects is must. Experience in 
writing Validation Plan, Validation Summary report and review of 
SDLC/project deliverables is must. Person should have very good knowledge 
of FDA regulations/GXP/21CFR Part 11

*Roles & Responsibilities*

•Ensures documentation and practices meet quality standards, 
applicable regulatory compliance and IS guidelines/policies
•Review functional design specification, technical design 
specifications for clarity, Good documentation practices.
•Review the accuracy and completeness of software validation 
deliverables created by process work streams
•Knowledge of software testing. Ability to create Traceability 
Matrices linking approved requirements to test cases within HPALM.
•Create validation deliverables like Requirements, Data Migration 
Plan, Summary Reports, work instruction documents for tools
•Ability to pull necessary details from an object level Technical 
Design Specs and Functional Design specs and consolidate the information in 
a Master Technical and Functional Design document that is presentable to an 
external regulatory agency.
•Experience working in an agile environment is preferre

 

 

Harish Karnala

United Software Group Inc.. 

565 Metro Place South. Suite # 110 
<https://maps.google.com/?q=565+Metro+Place+South.+Suite+%23+110++Dublin,+OH+43017=gmail=g>

Dublin, OH 43017 
<https://maps.google.com/?q=565+Metro+Place+South.+Suite+%23+110++Dublin,+OH+43017=gmail=g>
 

Direct Number : +1 614-408 1549

Board Number : 614-495-9222 EXT. 622

Fax: 1-866-764-1148

 

karnal...@usgrpinc.com 

www.usgrpinc.com

\

 

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