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Date: Jan 28, 2026

Location: Bangalore, KA, IN

Company: bioconbiolP2

Company Overview

Role Purpose

Supervisor - QA (AQA): oversees the Analytical Quality Assurance (AQA) team, ensuring that all analytical activities adhere to regulatory standards and internal quality guidelines. Responsibilities include supervising analytical testing, managing quality assurance processes, and addressing any quality issues. The objective is to ensure the accuracy and reliability of analytical results and maintain high standards of quality assurance.

Academic Stream

BIOTECHNOLOGY

Work experience (in months)

144

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.