Senior Executive- CQV (Quality Assurance)

Job Description

Designation Senior Associate CQV (Quality Assurance) Department Quality Assurance Experience 5+Years Job Location Bangalore 4+ years of experience in FDA-regulated industry Knowledge of pharmaceutical laboratory and process systems; Experience with Biologics equipment preferred Job Responsibilities: Take charge as Single Point of Contact for site validation/qualification (Equipment & Facilities) requirements. Responsible for scheduling, planning and ensuring execution of qualification/requalification (equipment, facility HVAC, Water system, Gases qualification) related to facility. Prepare and review of qualification / requalification protocols and reports. Perform thermal mapping activities for equipment available at site using Kaye Advanced Validator System. Draft and review of SOPs related to validation, Commissioning & Qualification. To manage change control, deviations, CAPAs, risk assessments related to Facilities & Equipment. To provide initial and regular training to team and other department personnel SOPs & protocols related to Validation, qualification/ requalification. Handling and maintenance of validation accessories & managing inventory. Identify and qualify service provider for validation services providers. Participate in External Service Provider (Engineering services) audits. Preparation of project & validation plan for facility expansion, capacity enhancement project. Take lead as Validation In-charge for new equipment & facility commissioning.