Company Overview

Role Purpose

Team Member-Quality-QC: EU Importation Testing Operations

Academic Stream

MSc, B.Tec

Work experience (in months)

6 to 12 years

Job Responsibility and key Decisions

EU Importation Testing Operations:

• • Role Overview

    We are looking for a highly motivated professional to lead and coordinate EU Importation Testing operations for commercial biologics supplied to European markets. The role involves managing testing activities through global Contract Testing Laboratories (CTLs), collaborating with European Qualified Persons (QPs), and ensuring timely product release while maintaining full regulatory compliance.

    Key Responsibilities

    • Drive end-to-end EU Importation Testing operations for commercial biologics.
    • Coordinate testing execution across global Contract Testing Laboratories (CTLs).
    • Partner with Qualified Persons (QPs), Supply Chain, Manufacturing, Regulatory Affairs, and Quality teams.
    • Develop product-wise testing forecasts and capacity plans.
    • Manage sample lifecycle from dispatch to CoA issuance.
    • Monitor testing progress, laboratory performance, and batch release timelines.
    • Lead resolution of testing delays, OOS, deviations, CAPAs, and change controls.
    • Review Certificates of Analysis (CoAs) and support EU batch certification.
    • Ensure compliance with EU GMP requirements, data integrity principles, and quality systems.
    • Drive continuous improvement initiatives focused on testing efficiency and supply continuity.

    Ideal Candidate Profile

    • 6-12 years of experience in QC, QA, analytical operations, biologics testing, or pharmaceutical quality systems.
    • Strong understanding of GMP, OOS, Deviations, CAPA, Change Control, and laboratory compliance.
    • Experience managing stakeholders, external laboratories, and cross-functional projects.
    • Excellent communication, problem-solving, and project management skills.
    • Hands-on experience with analytical equipment, Bioassay, BET, Sterility Testing, or related laboratory techniques is preferred.

    Preferred Qualification

    Candidates with significant hands-on Bioassay experience and strong technical expertise will be given preference.