EXECUTIVE

Date: Nov 13, 2025

Location: Bangalore, KA, IN

Company: bioconbiolP2

Company Overview

Role Purpose

The Team Member – Quality – QC – Finished Products is responsible for conducting analytical testing and evaluation of finished pharmaceutical products to ensure they meet predefined specifications and quality standards. This role involves performing a variety of physicochemical tests using validated methods, ensuring data integrity, maintaining laboratory instruments, and documenting results in compliance with current Good Manufacturing Practices (cGMP) and regulatory guidelines. The team member supports timely product release, stability testing, and investigation of out-of-specification (OOS) or out-of-trend (OOT) results, thereby playing a critical role in assuring the quality, safety, and efficacy of final drug products.

Academic Stream

0

Work experience (in months)

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Job Responsibility and key Decisions

Routine QC Testing of Finished Products

Perform and document analytical testing of batches according to regulatoryapproved methods.

Ensure results are within specification before batch release.

Result Reporting and Documentation

Accurately record and report test results in a timely manner.

Escalate any OOS or suspect results to the supervisor or QA immediately.

Compliance and SOP Adherence

Follow all relevant SOPs, test methods, and GMP practices.

Ensure test records are auditready at all times.

Instrument Qualification and Use

Use only qualified instruments and report any malfunctions.

Conduct routine checks and log maintenance activities.

Participation in Investigations

Support investigations into OOS results, lab deviations, and audit observations related to finished product testing.

Provide accurate and traceable data to support the process.

Sample Coordination and Disposal

Ensure proper labeling, handling, and tracking of finished product samples.

Dispose of tested materials as per SOP and environmental health and safety guidelines.

Continuous Improvement Participation

Suggest improvements in testing procedures or documentation practices.

Participate in lean lab, 5S, or Kaizen activities, if applicable.

DecisionMaking Scope

Make routine decisions on sample prioritization and minor troubleshooting under supervision.

Escalate critical issues or deviations to Team Lead or QC Manager.