The Role
Prepare and review quality management documents, plan and conduct system and study audits for IVRT, IVPT, and in-vitro studies, review protocols and analytical records, assess deviations, OOS, CAPA, change controls, and validation documents, deliver training, control documentation, verify computerized system compliance, support regulatory and sponsor audits, and manage sample retention activities.
Summary Generated by Built In
The candidate should have experience in IVRT and IVPT studies, as well as exposure to the Bioanalytical segment, preferably within the Quality Assurance or Operations department along with below job profile.
- To prepare and review the quality management system related documents like quality manual, SOPs etc. including review of technical SOPs.
- To plan and perform system audits and study audits of IVRT & IVPT or In-vitro studies to ensure compliance of approved documents.
- To review the study and/or project related documents like protocol, raw data, report, STP etc. for adequacy and accuracy.
- To review quality tools like incidents, change controls, deviations, OOS, CAPA, repeat analysis as per respective SOP.
- To review instrument qualification, calibration certificates and computerized system validation documents.
- To impart training on quality management system related documents like SOPs, quality policy etc.
- To issue and control documents as per document management system.
- To ensure computerized systems used for any stage of analysis are in validated state and relevant electronic data along with audit trails are reviewed.
- To face regulatory and or sponsor audit and involve in preparation of response for submission to regulatory agency and/or sponsor within time frame.
- To perform Sample retention related activities in absence of lab-coordinator/Pharmacist.
- Any Additional responsibilities given by Department In-Charge / Management.
Skills Required
- Experience in IVRT and IVPT studies
- Exposure to the bioanalytical segment
- Experience in Quality Assurance or Operations
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The Company
What We Do
Vitely provides analytical testing and laboratory services for life sciences organizations while developing enabling technology. Its VitelyBio division offers microbiology and in‑vitro testing and regulated lab processes; VitelyTech delivers software development, automation, and data‑management solutions to support R&D workflows, regulatory compliance, and data integrity for pharmaceutical and biotech clients. The company focuses on high-quality, compliant analytical services and integrated digital tools to accelerate discovery across regulated environments.
