MANAGER

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Date: Feb 2, 2026

Location: Bangalore, KA, IN

Company: bioconbiolP2

Company Overview

Role Purpose

Team Lead - DP In-Process QA: Manages the quality assurance activities during the drug product manufacturing process. This role ensures that all in-process quality controls are performed according to regulatory standards and internal guidelines. By leading a team, this position aims to promptly identify and resolve quality issues, maintaining high standards throughout production. The role is essential for ensuring that drug products meet required quality benchmarks and compliance throughout the manufacturing process.

Academic Stream

BIOTECHNOLOGY

Work experience (in months)

144

Job Responsibility and key Decisions

Should be well aware of Downstream process in relation to mammalian cell culture, having knowledge with chromatography techniques involved in Downstream process.

Preferably having overall knowledge on complete process of Biosimilars production by using mammalian cell culture. Along with above mentioned below GMP requirements also to be ensured in finalising the person for this position.

Handling of all IPQA related activities facility GMP compliance.

Review of master executed batch records and checklists.

Review of study protocols, process validation, cleaning validation etc protocols and reports.

Review of TTDs cell bank, inoculum and downstream.

Review of change control related to cell bank, inoculum and downstream.

Responsible for review of investigation reports pertaining to downstream deviations.

Responsible for ensuring processfacility related CAPA implementation and verification of CAPA effectiveness.

Responsible for supporting regulatory with required documents for filings.

Review and preparation of sitespecific QA SOPs.

Review of production SOPs.

Ensure audit readiness, shop floor oversight and GMP compliance, support in audit preparation, handling, and observation closure.

Review of CPV parameters from production, QC and control systems, and data trends

QA connect for new product initiation in DS manufacturing facility and cross functional requirement.