Urgent Requirement- Computer System Validation Consultant || Skillman, NJ (Onsite from Day-1) || Contract || HCL

Hi professional,

I hope you are doing well.

 

I have an urgent position for the following role. If interested, please share your resume at abhay@intellectt.com and call me at +1-7323557412.

 

Position Details
Job Location/Client Location (with City & State)	Skillman, NJ
Remote ok (Yes / No)	No (Onsite from Day-1)
Project Duration	6 Months
Project Start date	Asap
Job Title/Role	Computer System Validation Consultant
Mandatory Skills	Computer System Validation, Operations quality management
Client Interview Needed for Selection (Yes / No)	YES
Keywords – CSV, Computer System Validation, End to end validation, CSA, Computer System Assurance  Roles and Responsibilities  ·         Background and experience in AGILE SAFE methodology.  ·         Experience in the Pharmaceutical, biotechnology, or medical device industry ​  ·         3 to 7 years' experience in Computer System Validation ​  ·         Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.​  ·         Knowledge of FDA guidance's and industry standards (i.e., GAMP)​  ·         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, systems and UAT test scripts and Test procedures.​  ·         ​Ability to provide Validation guidance, timely reviews, and escalations to TQ management.​  ·         Perform Operational Change request in-process review for all Operational Changes ·         Contribute, track and drive IT deviations / exceptions/gaps to closure   ·         Post-event analysis of quality of Incident/Problem tickets to provide assurance that the required controls are adhered to, on a periodic basis   ·         Prepare applications for audits/assessments and provide support during audits/assessments   ·         Ensure applicable Controls are adhered to in the Application. Request for gaps as appropriate   ·         Involved during project transition, as quality manager by reviewing the User Requirements, Functional Risk Assessment, Validation Plan, Testing deliverables (IQ, OQ and PQ), Validation report.   ·         Always perform life cycle documents with respect to GDP   ·         Ensure that the validated state of the system is maintained  Handling the Deviation, RCA, CAPA, Change Management, Incident Management, Problem Management, Periodic Controls as per client policies/procedures

 

 

 

Thanks and Regards,

ABHAY SINGH

(TECHNICAL RECRUITER)

E-mail-  abhay@intellectt.com

DIRECT- +1-7323557412    EXT- 397

Company ID- www.intellectt.com

LinkedIn- https://www.linkedin.com/in/abhaysingh-chauhan/

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