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Sr SQA Validation Lead Position in Foster City, CA (Onsite from Day1) at Foster, Rhode Island, USA
Email: [email protected]
From:

Pavan Kumar,

Yochana IT

[email protected]

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This position is responsible for leading and performing activities in support of creating and maintaining GxP (GMP, GCP, GLP) quality and compliance environment for
SAP S/4 HANA. This position is also responsible for
monitoring Computer System validation (CSV) as well as compliance with GxP regulations and 21 CFR Part 11.

Leads the effort to manage, and/or maintains validation of SAP S/4 HANA system

Perform GxP and 21 CFR part 11 assessments and develop validation plan

Develop functional risk strategy and perform functional risk assessment

Review user business process documents and user requirements specification

Review functional, technical and configuration design documents

Prepare and/or review Configuration Qualification (CQ), Data Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and performance Qualification (PQ) protocols

Review the test scripts for the requirements and test scenario coverage

Lead overall protocol executions, log and track defects

Review the executed test reports for the proper documentation of test results and evidence

Review the defects for proper documentation per the checklist

Prepare and maintain the traceability matrix to ensure all the requirements are covered in design documents and tested

Prepare and approve qualification summary report

Participates in Corrective and Preventive Action (CAPA), Maintains quality metrics.

Maintain overall project and issue tracker and report routinely

Support release management activities by reviewing and ensuring the pre-requisites are completed prior to the release

Review Quality System support documentation including Standard Operating Procedures (SOP), Work Instructions (WI) and training materials

Maintain day to day activities status tracker and report routinely

Lead the team of validation engineers located in different time zones

Skills:

Excellent communication (oral and written) and attention to detail

8+ years in Computer System Validation in Life Science domain with minimum 3+ years of experience in managing large global SAP validation projects

Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.

Excellent knowledge of GxP regulations, FDA and EMEA guidelines including 21 CFR Part 11

Excellent knowledge of computer system validation and GAMP -5 standards

Keywords: sfour information technology Wisconsin
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Tue Jul 18 19:56:00 UTC 2023

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