QC Executive – Diagnostics Reagents

Arni Medica Pvt Ltd; Hyderabad; On-site; INR 500,000 - 900,000; Full time

Benefits offered by this job

Greenfield project

ISO 13485 CDSCO facility

Cross-functional collaboration

Competitive compensation

Career growth

Job summary

Arni Medica Private Limited in Patancheru, India, is hiring a Quality Control Executive for diagnostics reagents. You will perform raw-material, in-process and finished-product testing to ensure compliance with approved specs and product performance.

Role includes method validation, stability studies and investigations of atypical results, with exposure to clinical chemistry analyzers, ISE, UV-Vis, HPLC and related QC equipment.

Qualifications

• 2–5 years of QC experience in IVD reagents, clinical chemistry or a similar regulated environment.

Responsibilities

• Perform incoming raw-material inspection, 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.

Education

B.Sc / M.Sc in Chemistry, Biochemistry, Microbiology or Biotechnology

Tools

Clinical chemistry analyzer

ISE

UV-Vis spectrophotometer

HPLC

CLSI EP25

Westgard rules

IQC

GMP

ISO 13485

Calibrators & controls

Job description

Patancheru, India | Posted on 08/27/2026

Job Title:Quality Control Executive – Diagnostics Reagents

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:B.Sc / M.Sc 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.