Looking for Validation Lead/Specialist @ Parsippany, NJ

Dear Vendors,

Hope this note finds you well! We have an urgent requirement with one of our direct clients for the position of Validation Lead/Specialist @ Parsippany, NJ for a long term contract role. If you are interested, please share me your updated resume to sarath@selsoftinc.com / contact me at 214-509-8526.

H1B Copy Required

Role: Validation Lead/Specialist

Location: Parsippany, NJ

Duration:  Long term

Job Description:

·         Working experience in a regulated Pharmaceutical industry in the areas of Research/Lab areas.

·         Strong in Technical Writing

·         Strong expertise on lab system validation process including instrument decommissioning, calibration, and new lab set up etc.

·         Strong knowledge about pharmaceutical/medical device regulations like FDA 21 CFR Part 11, 21 CFR PART 210, 21 CFR PART 211.

·         Having experience writing Validation Master Plans, Risk assessment, Installation Qualification Protocols, Operational Qualification Protocols, Performance Qualification protocols, Summary reports and reviewing the validation deliverables for final sign off.

·         Experience in performing gap analysis, risk analysis, preparing mitigation plan along with knowledge of CAPA, handling deviations, Investigations.

·         Experience facing regulatory audits (USFDA/MHRA/TGA)

·         Excellent Communication Skills and relationship building with end user scientific community

·         Experience around SDLC documentation applicable to lab/instruments

Required:

·         Experience on Software validation like data migration, ERP/CRM or any other application related.

·         Experience on Team handling and on-site/off-shore model.

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Thanks & Regards

 

Sarathkumar – Talent Acquisition Team

Selsoft Inc.

D: 214-509-8526

Email: sarath@selsoftinc.com

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