SENIOR EXECUTIVE

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Date: Jan 29, 2026

Location: Bangalore, KA, IN

Company: bioconbiolP2

Company Overview

Role Purpose

Team Member-Quality-QA-DS-Analytical: Performs analytical quality assurance tasks to ensure the accuracy and reliability of analytical data. Responsibilities include executing tests, reviewing analytical procedures, and validating results to ensure compliance with quality standards. The objective is to support the integrity and accuracy of analytical data used in drug development and manufacturing processes.

Academic Stream

BIOTECHNOLOGY

Work experience (in months)

6

Job Responsibility and key Decisions

Analytical QA activities and monitoring, assuring the quality and GMP in QC biologicals.

Batch release of licensed and investigative drugs substance and approval of COA for biological products to customerregulatory agency as per their requirements.

Approval of analytical reports and its compliance as per the procedures defined in specifications, standard testing procedures, sops and meeting global compliance standard.

Technical review and management of analytical aspects of change controls and investigations such as deviations, OOS, OOT, laboratory incidents, OOC.

Monitoring and approval of analytical method validation, method transfer, and other studies conducted at quality control laboratory.

Ensuring appropriate instrument qualifications, DQ, IQ, OQ, PQ, RQ and calibration of QC lab equipments and instruments.

Performing analytical QA checks and cgmp rounds at QC analytical lab and implementation of CAPA.

Review and approval of specifications for IPFP of QC biologicals.

Review of standard operating procedures.

Providing documentation support to regulatory on analytical as per the customerregulatory requirement including standard, stability, AMV etc..

Review and approval of primary and secondary IRSworking standard laboratory standard impurity standardGC standard thawing time study of standards, review, and approval of all standard COA and reports.

PQR preparationreview of finished product quality attributes and stability study.

Coordinating and review of TTD, technical documents from RND, process validation protocols and reports.

Training of QA and QC department personnel on relevant proceduresubjects.

Coordinating for planning of stability studies, review, and approval of stability protocols, filing stability summaries, novatek stability summaries and other related documents w.r.t. Stability.

Establishing and preparation of the product trend limitreports.