ASSISTANT MANAGER

Date: Feb 3, 2026

Location: Bangalore, KA, IN

Company: bioconbiolP2

Company Overview

Role Purpose

Team Member-Quality-QA-RND: Assists in managing the Quality Management System (QMS) within Regulatory Quality Assurance (RQA). Duties include supporting QMS documentation and compliance activities, assisting with audits, and contributing to quality improvement initiatives. The aim is to ensure that the QMS effectively supports regulatory compliance and quality assurance within regulatory functions.

Academic Stream

SCIENCE

Work experience (in months)

12

Job Responsibility and key Decisions

Qualification and validation of equipments and utilities and other system.

Collaborate with CFT to ensure the project is complete on time.

Review and approval of Airflow Visualization Studies.

Review of the Master Validation Plan.

Review and approval of URS, SQRA, Trace model, Design SpecificationDesign.

Qualification, FAT protocolreport, CTP, SAT, IQ, OQ, IOQ, SOPEOP,

Preparation, review, and approval of Vendor Evaluations, CQMP, and GEP policies. Review of equipmentrelated SOPs.

Review of eVLMS related QMS elements.

ExecutionReview of Process Equipment, Temperature Controlled Equipment, Utilities, Gases, AreaAHULPS RQ.

Investigation of deviations.

Review of AMCOEMPMCalibration Planner.

Review of investigation reports related.

Review of production equipment breakdown assessment.

Review of all layouts except Personnel, Material, and Waste Movement layouts.

Review of Facility Review Procedure.

Review of decommissioning protocols and reports.

Creation of entities in eVL.