Job Title: Quality Control Executive – Diagnostics Reagents

Location: Hyderabad, India

Department: Quality Control

Experience: 2–5 years (QC in IVD reagents / clinical chemistry)

Employment Type: Full-time, on-site

About Arni Medica

Arni Medica Private Limited is an ISO 13485:2016 and ISO 9001:2015 certified medical device and in-vitro diagnostics (IVD) manufacturer based at the Medical Devices Park, Sangareddy (Hyderabad), Telangana. We design and manufacture nephrology, infusion therapy, respiratory care and surgical disposables, and are building a full IVD diagnostics franchise spanning clinical chemistry, electrolyte/ISE, blood gas (ABG), fluorescence immunoassay (FIA) and chemiluminescence immunoassay (CLIA) platforms — backed by Class 100K/10K cleanrooms, EtO sterilization and a CDSCO manufacturing licence (MFG/MD/2023/000942).

Role Overview

The QC Executive will perform raw-material, in-process and finished-product testing for diagnostics reagents to ensure compliance with approved specifications and product performance. The role also supports method validation, stability studies and investigation of atypical results.

Key Responsibilities

Perform incoming raw-material inspection, in-process QC (IPQC) and finished-product / batch-release testing of reagents.
Conduct analyzer-based performance checks, real-time and accelerated stability testing (per CLSI EP25 / ICH) and document results.
Apply Westgard rules / IQC; verify calibrators and controls; support method validation/verification and lot-to-lot consistency studies.
Operate and maintain QC instruments — clinical chemistry analyzers, ISE/electrolyte, UV-Vis spectrophotometer, HPLC, pH meter.
Support OOS / OOT investigations and root-cause analysis with QA and Production.
Maintain equipment calibration, GLP compliance, batch records (BMR), COA / COC and trend-analysis summaries.

Desired Candidate Profile

Education: https://jobeax.com/link/wOcGjnRrrRFUZzB4 / https://jobeax.com/link/MPrGoo1PSJpZ7d0e in Chemistry, Biochemistry, Microbiology or Biotechnology.
Experience: 2–5 years of QC experience in IVD reagents, clinical chemistry or a similar regulated environment.

Technical Skills & Keywords

Quality control, IVD reagents, lot / batch release, in-process QC, raw-material inspection, reagent stability, accelerated stability, CLSI EP25, Westgard rules, IQC,calibrators & controls, method validation/verification, lot-to-lot consistency, clinical chemistry analyzer, ISE, UV-Vis spectrophotometer, HPLC, COA / COC, BMR, GMP, ISO 13485.

Preferred / Good to Have

Stability-study design (CLSI EP25) and Westgard / IQC expertise.
HPLC, microbiology / media QC, or ISE / CLIA reagent QC.
ISO 13485 awareness and analyzer calibration experience.

What We Offer

A rare opportunity to help build a greenfield IVD diagnostics business from the ground up.
Modern, ISO 13485 / CDSCO-compliant manufacturing environment with cleanroom infrastructure.
Direct collaboration with R&D, Regulatory and senior leadership — visible impact, fast decisions.
Competitive compensation, commensurate with experience (negotiable; as per industry standards).
Accelerated career growth in a fast-scaling, export-oriented MedTech company.

How to Apply

Email your CV to jobs@arnimedica.com with the position title in the subject line.

QC Executive - Diagnostics Reagents

Start with your email