Company: Enzene Biosciences Ltd Designation: Senior Executive - DSQA Office Location: Chakan, Pune Primary 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 field Required Work Experience - Industry: Biopharma