Quality Assurance/Auditor Manager

• We are seeking a Quality Assurance (QA) Personnel/auditor with experience in Good Laboratory Practices (GLP) within a Contract Research Organization (CRO) and NABL.
• The ideal candidate will ensure compliance with GLP guidelines, regulatory requirements, and internal SOPs while supporting laboratory operations, audits, and documentation.
• ✔️ GLP Certification / QA Training in CRO
• QA experience in NABL and GLP-compliant laboratory within a CRO
• Strong knowledge of OECD GLP, ISO17025, ICH guidelines
• Strong understanding of GLP, data integrity, and compliance regulations.
• Excellent attention to detail, problem-solving, and organizational skills.
• Interaction with the representatives of Monitoring Authorities during GLP Inspections
• Inspection of all sections in the Test Facility and inspection of all GLP studies
• Planning and execution of audit program and preparing audit reports for approval from management
• Reviewing the protocols / study plan to verify the information required for compliance with Principles of Good Laboratory Practice and study/ test guidelines.
• Conduct independent internal audits / inspections to determine if all studies are conducted in compliance with the Principles of Good Laboratory Practice
• Conduct study based, process based and facility based inspections
• Conduct independent internal audits / inspections of critical phases of Acute, SubAcute, Reproduction toxicology studies, Analytical Chemistry studies including studies for determining Physical Chemical Properties, Analytical Method Validation, Batch Analysis studies
• Inspect Draft / Final Reports to confirm that the methods, procedures and observations are accurate and completely reported as per the study protocol along with raw data which is compliant with the Principles of Good Laboratory Practice.
• Conduct audits of SOPs, Master Schedules, Formats as per compliance with the Principles of Good Laboratory Practice.
• Implementation of CAPA
• Prepare and sign a statement, to be included in the final report which specifies types of inspections, their dates, phases of the study inspected and dates of reporting to Study Director and the Test Facility Management. This statement serves to confirm that the final report reflects the raw data.
• Quality assurance auditor for GLP preclinical toxicology, Genetic toxicology, and Analytical chemistry studies.
• To review Study Plan, Study Report, Raw data, SOP as per GLP and ISO guidelines.
• Risk assessment and preparation of SOPs, protocol
• To conduct audit on study, process and facility based to make sure GLP compliance and NABL standard
• To give training on OECD and ISO guidelines, SOPs
• Vendor evaluation and verify calibration data of equipments.

Interested candidates can share the profile to hr@vipragen.com

Location-Mysuru