do let me know if you have any one local or near to PA

Job Title: *Technical Writer**
*Location: Horsham, PA
Duration: 6 Months

*Job Description:**
*Validation Writer
Local to PA or within the driving distance only.
This document provides information for HR and recruitment purposes.

*Summary of role: **
*The Validation Writer is responsible for the planning, definition, design,
and delivery of full validation documentation associated with all Liquent
Software Solutions products.
The Validation Writer must utilize, promote and enforce the Liquent
Validation methodology, while adhering to strict document standards for all
work products.

When applicable, the Validation Writer elicits feedback from a team of
technical, application and business consultants, as well as customers to
fulfill the documentation requirements of the validation collateral.
These validation collaterals serve as work products, to be used by Liquent
resources and to be purchased by Liquent customers.

Furthermore, the Validation Writer serves as a focal point for all
communication with Liquent resources and customers on matters pertaining to
the assigned validation collateral.

The definition of "full validation documentation" includes (but is not
limited to) the following:
Validation Plan (template)
Functional Requirements Specification

Installation Qualification (IQ):
IQ Plan (template)
IQ Scripts
IQ Summary (template)

Operation Qualification (OQ):
OQ Plan (template)
OQ Scripts
OQ Summary (template)

Performance Qualification (PQ):
PQ Plan (template)
PQ Scripts (Template only)
PQ Summary (template)

Traceability Matrix
Validation Summary Report (template)

*Essential duties & responsibilities: **
*While other duties may be assigned, essential duties and responsibilities
include the following:
Develop and adhere to project plan and schedules.
Author, test and update all validation documentation for all Liquent
Software Solutions products, according to the approved validation
methodology.
Develop and package test documents for use in each product-specific
validation collateral.
Serve as a subject-matter expert of validation collateral to Liquent
Software Solutions resources or clients, or both.
Collect, organize and archive all validation project deliverables.
Promote and ensure the use of quality processes per validation and Standard
Operating Procedure (SOP) documentation.

Other essential duties and responsibilities include (but are not limited to)
the following:
Create, develop and maintain end-user documentation for Liquent software
products.
Contribute to the development of the company style guidelines for technical
documentation.
Provide information for project planning.
Contribute to UI design.
Provide information about product documentation when requested.

*Qualifications: **
*To perform this job successfully, the candidate must be able to perform
each essential duty satisfactorily.

The following requirements are representative of the knowledge, skill or
ability required:
Proficiency and experience writing computer systems validation documentation
Proficiency working in Microsoft Windows environments and with Windows-based
applications including (but not limited to) Microsoft Office products (such
as Microsoft Project), Adobe Acrobat, desktop publishing and graphics
packages.
Expert user of Microsoft Word.
Good experience of using HTML authoring tools and exposure to Daisy CMS
Ability to work well independently and in a team environment and to
multi-task in a complex environment.
Ability to learn new technology and to apply it to business needs.
Experience of document- and content-management systems.
Experience of software implementations.
Understanding of software validation requirements and the ability to execute
against defined plans.
Understanding of pharmaceutical industry and drug submission process.
Strong organizational, time-management, and interpersonal skills with a
customer service focus.
Detail-oriented.

*Education & experience:*
The following educational background or work experience (or both) is
required:
Three or more years experience in creating validation documentation
Understanding of the Life Sciences industry
Knowledge of regulatory submission content and formats (preferred).
Ability to articulate procedures and solutions to a multi-level team.
Strong interpersonal skills to conduct successful internal and client
interactions.

*Language skills: **
*Excellent written and oral communication skills are required for this role.

Reasoning ability

The following educational background or work experience (or both) is
required:
Problem formulation and solution-oriented reasoning (critical).
Ability to articulate and document procedural or product-related issues
under time pressures imposed by business-critical deadlines.




-- 
Thanks & Regards,

Ajay
Recruiter
Aclat Inc
Voice : 847-403-3200
Fax     : 847/577-2568
ajayavar...@aclatinc.net
www.aclatinc.com
Y IM : jas_vishwak

It is not a solicitation attempt!!!To be non-recepient/s, Please revert to
us, indicating "REMOVE" either in the subject line or in the Text. We
Apologize for the Inadvertent Incovenience.

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