QA Auditor

Role & responsibilitiesConduct external site audit (Late Phase) to ensure compliance with SOPs, Protocol, ICH GCP, and applicable regulatory requirements.Review of study documents like study protocol, inform consent, eCRF, Data management plan, study plans, Statistical analysis plan (SAP), clinical study report, etc.Audit study database in various clinical...

**Urgent Opening for the position of Quality Auditor/Quality Analyst for the Call Process in Bapunagar, Ahmedabad.** **Job Description (**Roles and Responsibilities)** - Monitor calls handled by agents as per the Sampling Plan. - Conduct regular joint discussions (Call Calibrations) every week. - Handle agent errors that are reported via messages. -...

Roles and ResponsibilitiesPrepare detailed reports on audit findings and recommendations for process improvements.Perform site monitoring visits to verify adherence to regulatory requirements and company standards.Collaborate with cross-functional teams to resolve issues related to study conduct, protocol violations, or deviations.Review data from CRFs, case...

About UsWe are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence.As a trusted voice for many of the world's most successful organizations, we...

Understanding of current regulatory expectations associated with In-Vitro BE studies (e.g., IVRT, IVPT, In Vitro Binding, BCS Biowaiver, etc.) and analytical services associated with pharmaceutical products including Microbiological tests. - Review of Method Validation / Study Sample Analysis Protocols, Method SOP, Raw Data, and Reports for In Vitro Analysis...

Medical Devices Experience will be Preferable Review Validation Protocols Internal Audits Requirements for ISO 13485 And Statutory Maintain Company System and Documents As Per Requirement Handle Customer Compliance And None Confirmative Given by Auditor Responsible For CE & Other Country’s Audit **Job Types**: Full-time, Permanent, Fresher Pay:...

Job Title: Quality Manager – MEPLocation: [Insert Location]Department: MEP / Quality Assurance & ControlJob Purpose:To ensure that all Mechanical, Electrical, and Plumbing (MEP) works are executed in compliance with project specifications, international codes, and client quality requirements. The Quality Manager (MEP) oversees the implementation of Quality...

Apply Description Greetings from Kashiv Biosciences!!!! We are looking for Qualification, Validation and QMS Engineer for our Engineering Team in our Biosimilar Manufacturing facility based out of Ahmedabad. Below are the roles and Responsibilities. Roles and Responsibilities Responsible for Engineering compliance, Equipment Qualification, Validation and QMS...

Role & responsibilitiesOff-site Monitoring• To undertake off-site visits during different phases of study period, as per study plan conduct Initial Site Visit to train and guide site personnel.• To inspect pre-requisite as per protocol and ensure site is ready for the study, undertake routine monitoring visits at predetermined frequency as per study...

Key Responsibilities:Lead and manage the QA & QC teams to ensure consistent product quality.Develop, implement, and monitor quality control procedures and inspection systems.Ensure compliance with buyer specifications, ISO standards, and industry norms.Conduct in-line, pre-final, and final inspections for production batches.Review fabric, trims, and garment...