Bhargava Marella
Audit & Compliance Management(Customer and Third party audits) | Data Integrity Remediation Plan | Regulatory Surveillance| Risk & Gap assessments | Atomization and digitalization |Data Governance| GXP
- Role
- Global Compliance Auditor at PQE Group
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Bhargava Marella
I lead global strategy and execution for GxP quality, regulatory compliance, and digital…
Experience
Global Compliance Auditor
Feb 2023 — Present · Hyderabad, IN
Dedicated compliance auditor highly regarded for success in scrutinizing the lab compliance, data integrity, Gap and risk assessments,• Develop, implement, manage, and track the effectiveness of corrective action plans for non-compliant issues, and provide management with regular updates.• Expertise in examining records, reports, operating practices, regulations, and documentation.• Exceptional interpersonal skills, with the ability to communicate risks and issues and work with Stakeholders to help them make informed decisions.• Completes all projects on time with the highest level of scrutiny and attention to detail to ensure results exceed expectations.• Coordinate, execute, and perform auditor/lead audit functions during internal and customer audits to ensure compliance with applicable regulations and international laws and standards, guidelines, and procedures.• Experience in support of Pharmaceutical Quality System compliance• Knowledge of development and review of FDA / EU cGMP compliance Assessment• Advanced experience in Computerized Systems Validation and related Electronic Records/Data Integrity Compliance through the development and execution of CSV compliance assessments• Knowledge of the main Project Management Methodologies both waterfall and agile.• Experience in development/review of project plans/Gantt, Project status update reports/presentation, project issues tracker and technical problem solving.• Effectively participated & managed regulatory audits for successful completion like US FDA, Infarmed, Health Canada, TGA and Halol.• Quality management ascertaining best-fit solutions for the observations identified.• Leading Crisis and Disaster management projects.• GxP Audit and Compliance Projects, Performed audits at API, Intermediate and FDF sites on behalf of international clients. Review compliance report and closing the audit.
Education
Rajiv Gandhi University of Health Sciences
Bachelor of Pharmacy - BPharm, Pharmacy
Jawaharlal Nehru Technological University
Diploma of Education, Pharmacy
Jawaharlal Nehru Technological University
Master in pharmacy, Pharmaceutical Analysis
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