QC Executive – Diagnostics Reagents

Arni Medica Pvt Ltd.; Hinoba-an; On-site; PHP 394,000 - 526,000; Full time

Job summary

Arni Medica Private Limited is seeking a Quality Control Executive for diagnostics reagents at our Patancheru site. You will perform raw-material, in-process, and finished-product testing to ensure compliance with specifications and product performance.

The role involves method validation, stability studies, and investigations of atypical results, with emphasis on CLSI EP25, Westgard rules, and proper calibration of clinical chemistry analyzers and related instruments.

Qualifications

• 2–5 years of QC experience in IVD reagents or clinical chemistry.
• Education in Chemistry, Biochemistry, Microbiology or Biotechnology.
• Familiarity with ISO 13485 and GMP practices is preferred.

Responsibilities

• Perform incoming raw-material inspection, IPQC and finished-product testing.
• Conduct analyzer-based performance checks and stability testing per CLSI EP25/ICH.
• Apply Westgard rules and verify calibrators and controls; support method validation.
• Operate QC instruments: clinical chemistry analyzers, ISE, UV-Vis, HPLC, pH meter.
• Assist in OOS/OOT investigations and root-cause analysis with QA and Production.
• Maintain calibration, GLP compliance, batch records, COA/COC and trend summaries.

Skills

Quality control

IQC

Westgard rules

CLSI EP25

HPLC

Clinical chemistry

ISO 13485

GMP

UV-Vis

Education

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

Tools

UV-Vis spectrophotometer

HPLC

COA / COC

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.