[14180MSCRMCV] || Validation Analyst || Foster City, CA || Exp.:6 years

Job Position:- Validation Analyst

Location:- Foster City, CA

Duration:- 6 Month

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JOB DESCRIPTION:-

 

Role:- Validation Analyst

 

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)
9. Excellent oral and written communication skills.

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In case you are not looking for the change at this point of time please refer your colleagues, Friends etc.

 

Regards,

Deepak

IDC Technologies, Inc

deep@idctechnologies.com

408-418-5778 ext-3001

Gtalk:deep.cit71

YIM:deepak_cit22

https://www.linkedin.com/profile/view?id=195002507

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