ASSISTANT MANAGER

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Date: Jan 29, 2026

Location: Bangalore, KA, IN

Company: bioconbiolP2

Company Overview

Role Purpose

The Team Member in Quality Assurance focusing on Documentation Specialist responsibilities within the Quality Management System (QMS) ensures that all quality documentation, including SOPs, protocols, reports, and records, are developed, controlled, maintained, and compliant with applicable regulatory and company standards. This role supports the establishment, implementation, and continuous improvement of the QMS by managing document lifecycle, facilitating training, and coordinating quality-related documentation activities to uphold compliance and facilitate audits and inspections.

Academic Stream

BIOPHARMACEUTICS

Work experience (in months)

36

Job Responsibility and key Decisions

Documentation Management

Create, review, update, and archive quality documents in compliance with SOPs and regulatory requirements.

Ensure timely routing of documents for review and approval.

Control and Maintenance of QMS Documents

Maintain an accurate and uptodate master document list and distribution list.

Monitor document expiration and revision cycles and initiate updates as necessary.

Support for Change Control and CAPA

Assist in documentation related to Change Controls, Deviations, CAPA, and other QMS processes.

Ensure that documentation associated with quality events is properly filed and tracked.

Training Coordination

Coordinate training on QMS documents and maintain training records.

Ensure personnel have acknowledged and understood relevant documents.

Audit Preparation and Support

Organize and provide documentation required for audits and inspections.

Support audit teams by ensuring documentation integrity and accessibility.

Continuous Improvement

Participate in initiatives to improve document management processes and QMS efficiency.

Recommend and implement best practices in documentation control.

Key DecisionMaking

Decide on document version control and archiving based on company policy.

Identify documents requiring urgent revisions or updates and escalate accordingly.

Ensure compliance with documentation standards and escalate noncompliance issues.