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Section: Other freelance job vacancies
Specialization: IT Consulting, Validation, FDA regulations
Available till: 2007-06-20
Wages: DOE
Contact info:
First, Last name: Ravi Gopal
E-mail: ravi@etekconsulting.com
URL: http://www.etekconsulting.com
Full description:
About us: ETEK Consulting is a provider of information technology consulting, staffing and business process outsourcing services, delivering quality people and optimizing business processes through a blend of on-site and offshore engagements for start-up and Fortune 1000 companies.
Description:
* Prepare standard validation documentation such as Installation Qualification Protocols, Operational Qualification (IQ/OQ) Protocols and Performance Qualification Protocols for the LIMS application.
* Work with the LIMS Development Team, as appropriate, to develop and validate LIMS as it is implemented and upgraded.
* Participate in and support the execution of validation activities.
* Able to work independently and with minimal supervision.
* Able to achieve deadlines and work to specific dates whilst maintaining quality.
* 3+ Years of computer validation experience in a GMP environment
* Strong working knowledge of GMP, 21 CFR Part 11, GAMP
* Excellent written and verbal communication skills including a demonstrated ability to participate in teams at all levels required
* Works with client management to identify and specify extremely complex business requirements and processes.
* Writes, enhances, and manages test scripts used for system, integration, and validation testing activities.
BACKGROUND:
- Knowledge of regulations and standards affecting Pharmaceutical Products (i.e., CFR 210/211, CGMP) preferred.
- Thorough understanding of SDLC and best practice methodologies / techniques expected.
- Experience in systems quality environment, or an equivalent combination of education and work experience.
- Good analytical ability, judgment, consultative and communication skills, and the ability to work effectively with clients and IT management and staff.
If you are qualified and interested and would like to be considered for this opportunity, please respond with resume in Word format along with a brief cover letter to - ravi@etekconsulting.com
Ravi or colleagues will review resumes and contact you.
NO CALLS PLEASE.
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