hyderabad, telangana
INR Not disclosed
On-site
Full Time
As a Clinical QA Auditor, you will be responsible for planning, conducting, and managing internal audits (Study Inprocess & Retrospective, System Audit) and Vendor audits in compliance with ICH-GCP, Protocol, SOPs, and applicable GxP standards/regulations. Your role will involve preparing audit reports, reviewing SOPs, study protocols, and clinical study reports, as well as assessing responses to audit findings and negotiating suitable actions for resolution. You will also be involved in reviewing deviations and CAPA plans, ensuring their implementation and closure, assisting in preparing the facility for client/sponsor audits and regulatory inspections, and performing document reconciliation for both Project and Non-project related documents. Additionally, you will review equipment calibration/validation records to maintain quality standards. To excel in this role, you should possess strong written and verbal communication skills, along with excellent analytical and problem-solving abilities. Good computer skills are essential, and being self-motivated with the ability to effectively prioritize work tasks is crucial. The ideal candidate will have a background in Life Sciences (B.Sc/M.Sc/B.Pharm/M.Pharm) and at least 2-5 years of experience in GCP quality assurance audits. A comprehensive understanding of ICH-GCP, US and EU regulations, and applicable GxP standards/regulations is required to ensure compliance and quality in auditing processes.,
hyderabad, telangana
INR Not disclosed
On-site
Full Time
As a Junior Research Associate in the Bioanalytical Research field, your responsibilities will include the operation and maintenance of various laboratory equipment. You will be required to handle biological samples, manage sample receipt and shipment, and procure biological matrix lots as needed. Additionally, you will be responsible for the operation, calibration, and maintenance of equipment such as deep freezers, refrigerators, Eurotherm, Thermo hygrometers, thermometers, centrifuge, evaporator, pH meter, balance, and pipettes. Furthermore, you will be involved in the management of biological samples including study samples, validation samples, and matrix lots. It will be crucial for you to maintain and archive relevant data in accordance with Standard Operating Procedures (SOPs) in coordination with the QC associate. The ideal candidate for this position should hold a B.Pharm or B.Sc. in Lifescience and possess 0-6 years of relevant experience. Strong attention to detail, organizational skills, and the ability to work effectively in a team are essential for success in this role.,
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