Position: Validation Lead, Richmond, VA

[Ashok Kumar]

Hi Partners,

Hope you are doing well.

Please let me know if you have anyone for below mentioned position with
resume and following details of your consultant.

Full Name/Phone/Email/Current Location/Availability/Rate



Position: Validation Lead

Location: Richmond, VA

Duration : 6 to 12 months



*Job Description:*

Experience Required: 8+ years

•Work experience in the FDA regulated Life Science industry.

•Manages computer system validation work, assuring the thoroughness of
validation planning and making appropriate progress towards completion of
validation work. Write technically sound computer system validation
protocols while adhering to company standards and regulatory expectations.

•Perform re-validation(OQ & PQ) and change control validation related
activities.

•Acts as liaison between Quality Assurance and the project team to assure
that GxP software is implemented in compliance with applicable regulations
and guidelines.

•Provides tactical direction and guidance for project teams implementing
Computer Systems for new or existing GxP systems including the development
and analysis of system requirements.

•Manages all validation aspects of several projects simultaneously.

•Ensure the compliance of computerized systems to regulatory requirements,
including but not limited to 21 CFR Parts 210, 211, Part 11 and Eudralex
Vol.4 - Annex 11.



*Thanks & Regards,*

*Ashok Kumar*

*Atika Technologies*

*5 Independence Way, Suite 300*

*Princeton, NJ 08540 Direct: 609-454-0103 <609-454-0103>*

*as...@atikatech.com *

*http://www.atikatech.com *

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Position: Validation Lead, Richmond, VA

[Ashok Kumar]

Hi Partners,

Hope you are doing well.

Please let me know if you have anyone for below mentioned position with
resume and following details of your consultant.

Full Name/Phone/Email/Current Location/Availability/Rate



Position: Validation Lead

Location: Richmond, VA

Duration : 6 to 12 months



*Job Description:*

Experience Required: 8+ years

•Work experience in the FDA regulated Life Science industry.

•Manages computer system validation work, assuring the thoroughness of
validation planning and making appropriate progress towards completion of
validation work. Write technically sound computer system validation
protocols while adhering to company standards and regulatory expectations.

•Perform re-validation(OQ & PQ) and change control validation related
activities.

•Acts as liaison between Quality Assurance and the project team to assure
that GxP software is implemented in compliance with applicable regulations
and guidelines.

•Provides tactical direction and guidance for project teams implementing
Computer Systems for new or existing GxP systems including the development
and analysis of system requirements.

•Manages all validation aspects of several projects simultaneously.

•Ensure the compliance of computerized systems to regulatory requirements,
including but not limited to 21 CFR Parts 210, 211, Part 11 and Eudralex
Vol.4 - Annex 11.



*Thanks & Regards,*

*Ashok Kumar*

*Atika Technologies*

*5 Independence Way, Suite 300*

*Princeton, NJ 08540 Direct: 609-454-0103 <609-454-0103>*

*as...@atikatech.com *

*http://www.atikatech.com *

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Position: Validation Lead, Richmond, VA(Need H1B Copy)

[Ashok Kumar]

Hi Partners,

Hope you are doing well.

Please let me know if you have anyone for below mentioned position with
resume and following details of your consultant.

Full Name/Phone/Email/Current Location/Availability/Rate

*Position: Validation Lead*

* Location: Richmond, VA Duration: 6+ months*

*Job Description:*
Participate in the development of strategic compliance deliverables to
support applicable
regulations and internal policies and to ensure that the systems to be
developed adhere to
corporate process methodology.
Drive the understanding and adoption of Quality and Compliance standards.
Ensure Quality & Compliance requirements are considered in any New Project
initiative
or Change request.
Assure that the compliance deliverables are updated and kept current with
all
applicable changes.
Work with IT and business teams to drive/maintain/create Quality
program. Align the development methodology with Compliance plans, policies
and procedures.
Effectively manage ongoing change control process (interface to IT support,
impact analysis,
release management, Data Management, testing, Audits etc.).
Build strong relationships with the Business owners.

*Qualifications*
5 - 9 years' experience in Pharma Quality & Compliance.
Experience in FDA regulated environment with good understanding
of cGxP (cGMP, cGDP,
cGAMP, cGLP) standards.
Experience in Computer system validation and knowledge of GAMP 5
Experience in writing and executing documentation for all aspects of the
validation
deliverables (Requirements, Compliance/validation Plans, test protocols,
Test Summary
reports and Compliance/validation reports (IQ,OQ,PQ).
Experience in reviewing system test and user acceptance test scripts,
Traceability matrix
and Design Specs.
Experience in Software Development Lifecycle (SDLC).
Experience in QA Methodologies, designing, reviewing and approving Test
Plans, systems
and UAT test scripts and Test procedures.
Experience in Change Management & Control.
Experience on various/any FDA standards (21 CFR Part 11, 210, 211, 820)
Experience is creation of SOPs.
Knowledge of FDA guidance's and industry standards (i.e., GAMP5)
Strong verbal and written communication skills.
Able to work as a team player, lead a team or accomplish tasks without
supervision.
Ability to work with remote teams and support several changes/projects
simultaneously.
Flexibility to work with an onshore/offshore model.
Preferred:
Knowledge of testing and Hands on experience in Client Quality Center and
QTP.
General
A Bachelors' degree
Excellent Communication Skills
Excellent Stakeholder Management Skills



*Thanks & Regards,*

*Ashok Kumar*

*Atika Technologies*

*5 Independence Way, Suite 300*

*Princeton, NJ 08540 Direct: 609-454-0103 <609-454-0103>*

*as...@atikatech.com *

*http://www.atikatech.com *

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Position: Validation Lead, Richmond, VA

[Ashok Kumar]

Hi Partners,

Hope you are doing well.

Please let me know if you have anyone for below mentioned position with
resume and following details of your consultant.

Full Name/Phone/Email/Current Location/Availability/Rate



Position: Validation Lead

Location: Richmond, VA

Duration : 6 to 12 months



*Job Description:*

Experience Required: 8+ years

•Work experience in the FDA regulated Life Science industry.

•Manages computer system validation work, assuring the thoroughness of
validation planning and making appropriate progress towards completion of
validation work. Write technically sound computer system validation
protocols while adhering to company standards and regulatory expectations.

•Perform re-validation(OQ & PQ) and change control validation related
activities.

•Acts as liaison between Quality Assurance and the project team to assure
that GxP software is implemented in compliance with applicable regulations
and guidelines.

•Provides tactical direction and guidance for project teams implementing
Computer Systems for new or existing GxP systems including the development
and analysis of system requirements.

•Manages all validation aspects of several projects simultaneously.

•Ensure the compliance of computerized systems to regulatory requirements,
including but not limited to 21 CFR Parts 210, 211, Part 11 and Eudralex
Vol.4 - Annex 11.



*Thanks & Regards,*

*Ashok Kumar*

*Atika Technologies*

*5 Independence Way, Suite 300*

*Princeton, NJ 08540 Direct: 609-454-0103 <609-454-0103>*

*as...@atikatech.com *

*http://www.atikatech.com *

-- 
You received this message because you are subscribed to the Google Groups "SAP 
ABAP" group.
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to sap-abap+unsubscr...@googlegroups.com.
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For more options, visit https://groups.google.com/d/optout.

Position: Validation Lead, Richmond, VA

[Ashok Kumar]

Hi Partners,

Hope you are doing well.

Please let me know if you have anyone for below mentioned position with
resume and following details of your consultant.

Full Name/Phone/Email/Current Location/Availability/Rate



Position: Validation Lead

Location: Richmond, VA

Duration : 6 to 12 months



*Job Description:*

Experience Required: 8+ years

•Work experience in the FDA regulated Life Science industry.

•Manages computer system validation work, assuring the thoroughness of
validation planning and making appropriate progress towards completion of
validation work. Write technically sound computer system validation
protocols while adhering to company standards and regulatory expectations.

•Perform re-validation(OQ & PQ) and change control validation related
activities.

•Acts as liaison between Quality Assurance and the project team to assure
that GxP software is implemented in compliance with applicable regulations
and guidelines.

•Provides tactical direction and guidance for project teams implementing
Computer Systems for new or existing GxP systems including the development
and analysis of system requirements.

•Manages all validation aspects of several projects simultaneously.

•Ensure the compliance of computerized systems to regulatory requirements,
including but not limited to 21 CFR Parts 210, 211, Part 11 and Eudralex
Vol.4 - Annex 11.



*Thanks & Regards,*

*Ashok Kumar*

*Atika Technologies*

*5 Independence Way, Suite 300*

*Princeton, NJ 08540 Direct: 609-454-0103 <609-454-0103>*

*as...@atikatech.com *

*http://www.atikatech.com *

-- 
You received this message because you are subscribed to the Google Groups "SAP 
ABAP" group.
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to sap-abap+unsubscr...@googlegroups.com.
To post to this group, send email to sap-abap@googlegroups.com.
Visit this group at https://groups.google.com/group/sap-abap.
For more options, visit https://groups.google.com/d/optout.

Position: Validation Lead, Richmond, VA

[Ashok Kumar]

Hi Partners,

Hope you are doing well.

Please let me know if you have anyone for below mentioned position with
resume and following details of your consultant.

Full Name/Phone/Email/Current Location/Availability/Rate

Position: Validation Lead
Location: Richmond, VA
Duration: 6+ months

Job Description:
Participate in the development of strategic compliance deliverables to
support applicable
regulations and internal policies and to ensure that the systems to be
developed adhere to
corporate process methodology.
Drive the understanding and adoption of Quality and Compliance standards.
Ensure Quality & Compliance requirements are considered in any New Project
initiative
or Change request.
Assure that the compliance deliverables are updated and kept current with
all
applicable changes.
Work with IT and business teams to drive/maintain/create Quality
program. Align the development methodology with Compliance plans, policies
and procedures.
Effectively manage ongoing change control process (interface to IT support,
impact analysis,
release management, Data Management, testing, Audits etc.).
Build strong relationships with the Business owners.

Qualifications
5 - 9 years' experience in Pharma Quality & Compliance.
Experience in FDA regulated environment with good understanding of cGxP
(cGMP, cGDP,
cGAMP, cGLP) standards.
Experience in Computer system validation and knowledge of GAMP 5
Experience in writing and executing documentation for all aspects of the
validation
deliverables (Requirements, Compliance/validation Plans, test protocols,
Test Summary
reports and Compliance/validation reports (IQ,OQ,PQ).
Experience in reviewing system test and user acceptance test scripts,
Traceability matrix
and Design Specs.
Experience in Software Development Lifecycle (SDLC).
Experience in QA Methodologies, designing, reviewing and approving Test
Plans, systems
and UAT test scripts and Test procedures.
Experience in Change Management & Control.
Experience on various/any FDA standards (21 CFR Part 11, 210, 211, 820)
Experience is creation of SOPs.
Knowledge of FDA guidance's and industry standards (i.e., GAMP5)
Strong verbal and written communication skills.
Able to work as a team player, lead a team or accomplish tasks without
supervision.
Ability to work with remote teams and support several changes/projects
simultaneously.
Flexibility to work with an onshore/offshore model.
Preferred:
Knowledge of testing and Hands on experience in Client Quality Center and
QTP.
General
A Bachelors' degree
Excellent Communication Skills
Excellent Stakeholder Management Skills

*Thanks & Regards,*




*Ashok KumarAtika Technologies5 Independence Way, Suite 300Princeton, NJ
08540 Direct: 609-454-0103*
*Email: **as...@atikatech.com* 
*http://www.atikatech.com* 

-- 
You received this message because you are subscribed to the Google Groups "SAP 
ABAP" group.
To unsubscribe from this group and stop receiving emails from it, send an email 
to sap-abap+unsubscr...@googlegroups.com.
To post to this group, send email to sap-abap@googlegroups.com.
Visit this group at http://groups.google.com/group/sap-abap.
For more options, visit https://groups.google.com/d/optout.

Position: Validation Lead, Richmond, VA

[Ashok Kumar]

Hi Partners,

Hope you are doing well.

Please let me know if you have anyone for below mentioned position with
resume and following details of your consultant.

Full Name/Phone/Email/Current Location/Availability/Rate

Position: Validation Lead
Location: Richmond, VA
Duration: 6+ months

Job Description:
Participate in the development of strategic compliance deliverables to
support applicable
regulations and internal policies and to ensure that the systems to be
developed adhere to
corporate process methodology.
Drive the understanding and adoption of Quality and Compliance standards.
Ensure Quality & Compliance requirements are considered in any New Project
initiative
or Change request.
Assure that the compliance deliverables are updated and kept current with
all
applicable changes.
Work with IT and business teams to drive/maintain/create Quality
program. Align the development methodology with Compliance plans, policies
and procedures.
Effectively manage ongoing change control process (interface to IT support,
impact analysis,
release management, Data Management, testing, Audits etc.).
Build strong relationships with the Business owners.

Qualifications
5 - 9 years' experience in Pharma Quality & Compliance.
Experience in FDA regulated environment with good understanding of cGxP
(cGMP, cGDP,
cGAMP, cGLP) standards.
Experience in Computer system validation and knowledge of GAMP 5
Experience in writing and executing documentation for all aspects of the
validation
deliverables (Requirements, Compliance/validation Plans, test protocols,
Test Summary
reports and Compliance/validation reports (IQ,OQ,PQ).
Experience in reviewing system test and user acceptance test scripts,
Traceability matrix
and Design Specs.
Experience in Software Development Lifecycle (SDLC).
Experience in QA Methodologies, designing, reviewing and approving Test
Plans, systems
and UAT test scripts and Test procedures.
Experience in Change Management & Control.
Experience on various/any FDA standards (21 CFR Part 11, 210, 211, 820)
Experience is creation of SOPs.
Knowledge of FDA guidance's and industry standards (i.e., GAMP5)
Strong verbal and written communication skills.
Able to work as a team player, lead a team or accomplish tasks without
supervision.
Ability to work with remote teams and support several changes/projects
simultaneously.
Flexibility to work with an onshore/offshore model.
Preferred:
Knowledge of testing and Hands on experience in Client Quality Center and
QTP.
General
A Bachelors' degree
Excellent Communication Skills
Excellent Stakeholder Management Skills

*Thanks & Regards,*




*Ashok KumarAtika Technologies5 Independence Way, Suite 300Princeton, NJ
08540 Direct: 609-454-0103*
*Email: **as...@atikatech.com* 
*http://www.atikatech.com* 

-- 
You received this message because you are subscribed to the Google Groups "SAP 
ABAP" group.
To unsubscribe from this group and stop receiving emails from it, send an email 
to sap-abap+unsubscr...@googlegroups.com.
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For more options, visit https://groups.google.com/d/optout.