SENIOR MANAGER

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Date: Feb 2, 2026

Location: Bangalore, KA, IN

Company: bioconbiolP2

Company Overview

Role Purpose

The Specialist – Quality Assurance plays a critical role in ensuring that pharmaceutical products are developed, manufactured, and released in compliance with applicable quality standards, regulatory requirements, and company policies. The Specialist supports the QA function by reviewing documentation, managing quality systems, conducting audits, supporting investigations, and facilitating compliance with cGMP and regulatory expectations to uphold product quality and patient safety.

Academic Stream

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Work experience (in months)

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Job Responsibility and key Decisions

Documentation Review

Review manufacturing batch records, laboratory data, and quality documents for accuracy and compliance prior to batch release or product disposition.

Deviation and CAPA Management

Support the investigation and documentation of deviations and nonconformances.

Assist in the development and monitoring of CAPAs.

Audit Support

Prepare audit documentation and assist with internal and external audits.

Track audit findings and ensure timely closure of corrective actions.

Change Control and Risk Management

Participate in change control assessments related to manufacturing processes or quality systems.

Support risk assessments to ensure compliance and quality impact evaluation.

Training and Compliance Tracking

Coordinate and monitor training activities related to quality standards and procedures.

Quality Improvement Initiatives

Participate in projects aimed at improving quality systems and processes.

DecisionMaking Scope

Make routine decisions related to document review and minor quality deviations within established guidelines.

Escalate critical quality issues or deviations to QA leadership.