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