SENIOR EXECUTIVE KA

Company Overview

Role Purpose

The Team Member - Quality - QC - Bio Assay is responsible for conducting bioassays to test and verify the biological activity, potency, and quality of pharmaceutical products. This role ensures that bioassays are executed in accordance with validated procedures, regulatory guidelines, and Good Laboratory Practices (GLP). The team member collaborates with other Quality Control personnel to ensure accurate testing, documentation, and analysis of results. They play a critical role in maintaining the integrity of pharmaceutical products by providing reliable bioassay data to support product release and regulatory compliance.

Academic Stream

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Work experience (in months)

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Job Responsibility and key Decisions

Perform Routine and NonRoutine Bioassays

Execute bioassays on raw materials, inprocess samples, and finished products as per approved protocols.

Ensure testing is completed within scheduled timelines.

Prepare and Maintain Cell Cultures

Culture and maintain cell lines, ensuring viability and suitability for bioassays.

Prepare reagents and assay components with precision.

Data Recording and Reporting

Document experimental procedures and results in realtime.

Prepare analytical reports for review and support batch release.

Support Investigations

Assist in the investigation of assay failures or outofspecification results.

Participate in root cause analysis and implementation of corrective actions.

Equipment Maintenance

Perform routine equipment checks and maintenance.

Notify supervisors of any instrument malfunctions or issues.

Ensure Compliance and Quality

Follow all GMP, GLP, and safety guidelines during testing.

Maintain cleanliness and organization of the bioassay laboratory.

DecisionMaking Scope

Make routine decisions related to assay setup and execution within SOP guidelines.

Escalate critical quality or compliance issues promptly to Team Lead or QC Manager.