Fwd: Urgent Requirement:Validation Analyst @ Foster City, CA

Hi Associate,

We have an Urgent opening .Please see the Job Description Below and let me know if you have any consultant available.

Role       Validation Analyst

Location: Foster City, CA
Duration: 6 months +

 

PRIMARY DUTIES AND RESPONSIBILITIES:

 

Mandatory Technical Skills          

• Strong hands-on experience in Software testing in the Pharmaceutical and/or Medical Devices industries

• Experience in Software validation and compliance activities in pharma (GMP) environment

• Experience in working with GxP, SOX, Data Privacy applications

• Should have good understanding of change management process

• Experience in the use of HP Quality Center and similar tools to manage software testing and requirements

 

Functional Skills              

1. Experience in Information Technology, hands on computer system validation activities. Worked in cGMP, 21 CFR Part11 and GAMP 5 environment. Hands on authoring/ review/ approval of computer system validation deliverables, inclusive of requirements gathering.  Functional specification, test/validation plans, protocols, test scripts / cases, traceability matrix and summaries.

2. Experience in the pharmaceutical or biotech industries supporting IT initiatives

3. Demonstrated skills for independently guiding quality and compliance activities during system application design, development and deployment in the pharma industry.

4. A minimum of a Bachelors degree in sciences

5. Demonstrated ability to communicate effectively with individuals and groups at multiple levels across the organization

6. Ability to work independently, manage multiple priorities, and work in an unstructured environment

7. Experience managing activities within medium to large scale IT projects

8. Experience with risk based approaches to validation (GAMP 5)

 

Thanks 

Wasim Ahmed
United Software Group Inc.. 
565 Metro Place South. Suite # 110 
Dublin, OH 43017 
Phone:  614-495-9222 ext 494
Fax: 1-866-764-1148 
wasimahmed@usgrpinc.com 
www.usgrpinc.com

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