QC Analyst – IVD 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

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.