Diverse Lynx
Position: GxP Test Lead
Location: Raritan, NJ
Job Description:
Lead end-to-end validation and testing efforts for GxP-compliant systems (e.g., LIMS, ERP, MES, QMS, CSV systems).
Develop and execute validation deliverables including Validation Plan, Risk Assessment, Test Strategy, IQ/OQ/PQ protocols, and Summary Reports.
Ensure all testing complies with regulatory standards such as GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and company SOPs.
Collaborate with business users, QA, and IT teams to ensure software validation aligns with GxP requirements.
Define and maintain traceability between user requirements, design specifications, and test results.
Review and approve validation documentation, ensuring completeness and accuracy.
Identify risks and gaps in validation activities and drive remediation.
Support audits and inspections by regulatory bodies and clients.
Provide training and guidance on CSV (Computer System Validation) best practices to testing teams.
Manage defect tracking, issue resolution, and test closure reporting.
Thanks & Regards,
Shashi Bhushan
Diverse Lynx LLC |300 Alexander Park|Suite #200|Princeton , NJ 08540
Office: +732-452-1006 ext:344
Email: shashi.bhushan@diverselynx.com | URL: http://www.diverselynx.com
Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.
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Location: Raritan, NJ
Job Description:
Lead end-to-end validation and testing efforts for GxP-compliant systems (e.g., LIMS, ERP, MES, QMS, CSV systems).
Develop and execute validation deliverables including Validation Plan, Risk Assessment, Test Strategy, IQ/OQ/PQ protocols, and Summary Reports.
Ensure all testing complies with regulatory standards such as GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and company SOPs.
Collaborate with business users, QA, and IT teams to ensure software validation aligns with GxP requirements.
Define and maintain traceability between user requirements, design specifications, and test results.
Review and approve validation documentation, ensuring completeness and accuracy.
Identify risks and gaps in validation activities and drive remediation.
Support audits and inspections by regulatory bodies and clients.
Provide training and guidance on CSV (Computer System Validation) best practices to testing teams.
Manage defect tracking, issue resolution, and test closure reporting.
Thanks & Regards,
Shashi Bhushan
Diverse Lynx LLC |300 Alexander Park|Suite #200|Princeton , NJ 08540
Office: +732-452-1006 ext:344
Email: shashi.bhushan@diverselynx.com | URL: http://www.diverselynx.com
Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.
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