Looking for Validation Tester

[Manu Priya]

Role: Validation Tester

Location: Berkley, CA

Duration: 6 Months





•Perform analytical computerized instrument and software
validation, spreadsheet validation

•and validation periodic review to support a variety of the labs
within QC organization.

•Prepare IOQ and other life cycle documents with high quality and
accuracy.

•Write validation protocols and final reports and function as a
validation SME. Conduct

•computer and software validation, validation periodic review, and
Validation Status List

•management.

•Ensure validations are within compliance by following industry
standards, corporate policy,

•and regulatory requirement. Interact with Regulatory agencies,
customer, and internal

•auditors/inspectors as needed. Support regulatory filings with
documentation as needed.

•Write and/or revise SOPs, and maintain all validation related
documentation.

•Manage multiple projects with ability to trouble shoot and seek
solution.

•Frequently acts as an expert and technical resource to laboratory
staff and cross functional

•areas.

•Commitment to safety by following and promoting programs regarding
health, safety and

•protection of environment.

•Coordinate vendors in support of validation projects.

•Minimum Education:

•Bachelor’s Degree in Science or Engineering



*Skills:*



•5-6 years of experience in pharmaceutical or related industry or
an equivalent combination

· of education and experience.

•2+ years’ experience in performing analytical computerized
instrument and software

· validation.

•Strong understanding of cGMP, 21 CFR Part 11, global regulatory
compliance.

•Strong technical/business writing and communication skills.

•Knowledge in risk assessment, gap analysis, changes control and
deviation management.

•Strong computer skills, including Word, Excel, PowerPoint and
databases.

•Strong understanding of Empower.

•Must be able to demonstrate knowledge of validation principles,
including user

· requirements, system specifications, IQ, OQ, and PQ.

•Ability and initiative to work with minimal supervision required.

•Strong ability to plan and prioritize complex and conflicting
objectives to meet release goal.

•Excellent organizational skills, capable of multi-tasking and
creating validation/qualification

· documents for multiple projects simultaneously.

•Experience in change control, deviation investigations, and CAPA
to ensure compliance.





*Thanks and Regards,*



*Manu Priya*

*Sr. Technical Recruiter*

*IDC Technologies*

*1851 McCarthy Boulevard, Suite 116|Milpitas, CA , USA, 95035*

*408-459-5794 [Direct]  I **manu.pr...@idctechnologies.com*


*www.idctechnologies.com* 



*Note: **Due to high volume of calls, I may miss your call, email is the
better way to reach me.*

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Looking for Validation Tester @ Boston, MA - ​Only GC and USC

[Syed Ali]

**Please send resumes to a...@imgsystems.com *

​Hi Associate,

Find the requirement below and get back to me with perfect resource.

Check the skills before sending the resume.


*Only GC and USC*

*​​*

*Role*:
​
Validation / Tester

*Location*: Boston, MA

*Duration*: 6+ months

*Skills:*

· *Client is looking for candidates with experience in developing
test script, ERP integration, CSV, and SAP*
· *Must have biotech/pharma experience*
​

​​
​Please provide following details with resume to process more quickly.

Name:

Phone:

Email:

Rate:

Current Location:
Status: (Citizen, Green Card, TN, H1B):​

-- 
Thanks

Syed Ali
Email : a...@imgsystems.com
Gtalk : ali.imgsys...@gmail.com
Phone : 972-210-2767 X 103
IMG Systems Inc.

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