Job DescriptionCompany: Enzene Biosciences LtdDesignation: Senior Executive - DSQAOffice Location: Chakan, PunePrimary Responsibilities:Shop floor compliance- Routine shop floor rounds in manufacturing and warehouse to ensure consistent quality of product.- Follow up for shop floor compliance against findings in manufacturing and warehouse.- Line clearance of batches manufactured in Bio bulk manufacturing and Dispensing activity of Raw/Consumable materials for Bio bulk manufacturing.- Monitoring of upstream and downstream process.- Review of Facility management trends, Review of Environmental Monitoring trends for Batch release, Microbial intimation and its investigation for BBM Facility.- Support for GEMBA walk and its compliance verification.Quality management System- Review of Change control,



deviation/OOS/OOT investigation of bio bulk manufacturing and warehouse.- Review of corrective and preventive action & its effectiveness verification.- Review of Risk assessment- Initiation of CAPA, Change control and their timely closure in AQEM Master Control.- Preparation of general study protocol & reports in Master Control.- Client notifications regarding the initiated QMSs as per the SOP.Annual Product Quality Review- Preparation & review of annual product quality review of Bio Bulk Products manufactured in Enzene Bioscience Ltd.- Review of Continuous process verification for Bio Bulk Products manufactured in Enzene Bioscience Ltd.Educational Qualifications Preferred- MSc, M Pharma in related fieldRequired Work Experience- Industry: Biopharma- Role: IPQA - DS- Years of experience: 5 to 9

📌 Senior Executive - Ipqa (Ds) (Pune)
🏢 Enzene Biosciences
📍 Pune