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
Role: IPQA - DS
Years of experience: 5 to 9

📌 Senior Executive Ipqa Ds Pune
🏢 Enzene Biosciences
📍 Pune