Hi
I hope you are doing well.
We have an urgent position listed below. Please send your most recent resume along with the expected rate if you are interested.
Job Role: Validation Lead -CSV with Annex 11 Remediation
Location: Raritan, NJ(Hybrid)
Visa: USC/GC/H1B
Job Description:
Job Details:
5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on experience in retro-validation activities and 21 CFR remediation projects with knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness.
Experience in the Pharmaceutical, biotechnology, or medical device industry
Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports
Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs.
Experience in QA Methodologies, designing, reviewing and approving Test Plans, System/UAT test scripts and Test procedures.
Strong verbal and written communication skills.
Ability to work as a team player, lead a team or accomplish tasks without supervision.
Ability to work with remote teams and support several changes/projects simultaneously.
Ability to provide Validation guidance, timely reviews, and escalations to TQ management
Thanks & Regards
SHIV PRASAD | Raas Infotek Corporation
IT Talent Acquisition | Recruitment | Staffing Solutions
302-286-9740 Ext. 135 | [email protected]
⌂ 262 Chapman Road, Suite 105A, Newark, DE 19702