GCP Auditor

• Support the strategic development of an effective global risk-based audit strategy and program for clinical trials.
• Conduct of quality reviews of protocol, reports in addition to audit of tables, figures and listings and other supplementary clinical trial documentation.
• Conduct external site and vendor audits and provide support in preparation, review and finalization of audit reports.
• Draft QA (Quality Assurance) SOPs (Standard Operating Procedures). Review and provide QA inputs for functional SOPs.
• Continued maintenance of clinical QA systems with written standard operating procedure (SOPs).
• Provide support in local and global Health Authority (HA) inspections and third party audits.
• Review, evaluate and approve proposed corrective and preventive action plans (CAPA) in collaboration with the responsible business unit.
• Maintain database of quality issues reported to QA.
• Perform timely management of audit metrics
• Coordinate training management for clinical development and support in uploading role specific training on Learning Management System.
• Maintenance of vendor management database.
• Support for implementation of Data Management System (DMS) and continual maintenance
• Coordinate archive management.
• Assist in management of controlled documents.

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We are committed to providing access to affordable and innovative medicines, driven by our purpose of Good Health Cant Wait.Our products and services are spread across our core businesses of Active Pharmaceutical Ingredients (API), generics, branded generics, biosimilars and over-the-counter pharmaceutical products around the world. We work towards meeting unmet patients needs in the areas of gastro-enterology, cardiovascular, diabetology, oncology, pain management and dermatology. We are investing in businesses of the future including drug discovery, clinically-differentiated assets and digital healthcare.