Quality Assurance- GLP

MS CLINICAL

8 - 12 years

0 Lacs

karnataka

Posted:3 days ago| Platform: Shine logo

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Skills Required

quality assurance glp regulatory guidelines root cause analysis compliance training communication presentation stakeholder management clinical research pharmaceuticals life sciences regulatory audits capa root cause analysis computerized system validation ichgcp clinical qa processes audits capa management continuous quality improvement documentation standards sop management quality risk management methodologies good documentation practices gdp crossfunctional collaboration ngcma guidelines internal external auditing vendor audits good documentation practices gdp electronic qa systems

Work Mode

On-site

Job Type

Full Time

Job Description

As a Quality Assurance GLP professional at MSCR, your role involves ensuring the highest standards of quality and compliance across clinical research and laboratory operations by leveraging your expertise in ICH-GCP and GLP principles. You will be responsible for various key activities: - Develop and maintain ICH/GCP-compliant processes at MSCR. - Lead internal quality audits, CAPA activities, and quality management reviews. - Conduct study audits to ensure adherence to sponsor protocols, GCP, and regulatory requirements. - Identify non-conformances, recommend corrective measures, and drive continuous quality improvements. - Perform vendor audits, collaborate with production support teams, and implement root cause analysis techniques. - Deliver training sessions to MSCR staff on QA processes and compliance. - Support the review and implementation of new technology products and equipment. In terms of GLP compliance and audits, your responsibilities will include: - Ensuring compliance with OECD GLP principles and NGCMA guidelines. - Planning, conducting, and reporting inspections. - Verifying adherence to GLP requirements in study protocols, SOPs, and raw data. - Maintaining inspection schedules and records. You will also be involved in documentation and SOP management, study oversight, regulatory liaison, training, and continuous improvement initiatives. To be successful in this role, you should have: - 8-10 years of experience in Quality Assurance within clinical research, pharmaceuticals, or life sciences. - Strong knowledge of ICH-GCP guidelines, OECD GLP principles, and regulatory requirements. - Proven experience in internal and external auditing, CAPA management, and root cause analysis. - Understanding of Good Documentation Practices and quality risk management methodologies. - Excellent communication, presentation, and training skills. - Ability to work cross-functionally and manage multiple stakeholders. Preferred qualifications include prior experience in a Clinical Research Organization, handling regulatory inspections, and knowledge of electronic QA systems.,

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