Senior Executive - IPQA (DS)

Enzene Biosciences Ltd; Maharashtra; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Enzene Biosciences Ltd in Pune seeks a Senior Executive - DSQA to ensure quality on the shop floor, manage batch release support, and uphold environmental and facility monitoring standards. You will drive CAPA initiation, change control, and QMS activities within the Bio Bulk Manufacturing domain.

The ideal candidate holds MSc or M Pharma with 5–9 years of biopharma experience, and will contribute to annual product quality reviews and risk assessments as part of the QA team.

Qualifications

• Qualifications in pharma/biotech with MSc or M Pharma.
• Experience in biopharma QA, IPQA/DS roles preferred.
• Knowledge of CAPA, change control and QMS processes.

Responsibilities

• Perform routine shop floor rounds to ensure product quality.
• Ensure compliance against findings in manufacturing and warehouse.
• Line clearance for BBM batches and material dispensing activities.
• Monitor upstream and downstream processes and environmental trends.
• Support GEMBA walks and verify compliance.
• Review CAPA, change control and QA documentation and APQR activities.

Skills

Shop floor compliance

Quality systems

GEMBA walk

CAPA & QMS

Education

MSc

M Pharma

Job description

Key Responsibilities

• 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.

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