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I am Akshay Kumar from Global Applications Solution, writing this email to share few exciting Job Opportunity with one of our premium clients.
If you are interested, please share resume on my email – [email protected]
Job Description: Life Science Validation Engineer (Remote)
Location: Preferably East Coast (Philadelphia, PA; New York, NY; New Jersey; New Hampshire)
Contract Type: Remote
Client: Jade Global
Overview:
We are seeking a highly experienced Senior ERP Validation Consultant to join our client, Jade Global, in a remote role. This position requires in-depth expertise in Computer Systems Validation (CSV), ERP platforms such as SAP, NetSuite, and Oracle Fusion, and a strong understanding of industry regulations. The ideal candidate will have a track record of leading global life sciences companies in validating ERP systems, with a focus on compliance and quality assurance processes in the pharmaceutical and medical device industries.
Key Responsibilities:
· Lead and drive Computer System Validation (CSV) efforts for ERP platforms such as SAP, NetSuite, Oracle Fusion, and other cloud-based solutions.
· Establish and manage Validation Master Plans (VMP) and Validation Risk Assessments.
· Develop and implement IQ/OQ/PQ test protocols for ERP systems validation.
· Create and maintain an approval matrix for all validation deliverables.
· Coordinate and collaborate with offshore testing teams to ensure the execution of formal validation test scripts.
· Oversee the validation test execution process with business units, ensuring defect management and timely resolution.
· Implement and manage robust change control processes for ongoing validation efforts.
· Advise and consult business QA leaders on best practices for CSV and compliance with regulations such as 21 CFR Part 11, 21 CFR Part 820, and EU Annex 11.
· Keep updated with the latest industry regulations, ensuring all activities comply with current standards.
· Provide leadership in ensuring validation compliance for pharmaceutical, biotech, and medical device supply chains, manufacturing, and QA processes.
Qualifications:
· Education: Bachelor’s degree required; Master’s degree preferred.
· Experience:
o 10+ years of experience in Computer Systems Validation (CSV), with a deep understanding of Pharma/Biotech/Medical Devices industries.
o Proven experience in validating ERP systems, particularly Cloud ERP platforms (SAP, NetSuite, Oracle Fusion).
o Significant experience with 21 CFR Part 11, 21 CFR Part 820, and EU Annex 11.
o Extensive background working with global life sciences companies, managing validation efforts across US and international locations.
· Skills:
o Strong consulting, presentation, and communication skills.
o Expertise in ERP validation, especially cloud-based platforms.
o Experience in Validation Risk Assessments and Validation Master Plan creation.
o Ability to collaborate with multiple stakeholders including offshore teams, business units, and QA leaders.
o Strong problem-solving skills for defect management and validation process improvement.
o In-depth knowledge of compliance and regulatory requirements in the life sciences sector.
Thanks & Regards,
Akshay Kumar
Talent Acquisition- Recruitment
Global Applications Solution LLC(USA)
#1 Meadowlands Plaza, Suite 216. East Rutherford, NJ 07073.
Office USA: +1 201-578-7586| WhatsApp: +91 7562 863220
📧[email protected]
https://www.linkedin.com/in/itsakshaykrs/
www.globalapplications.com
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