02 Oct
|
Arni Medica
|
Hyderabad
02 Oct
Arni Medica
Hyderabad
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: B.Sc / M.Sc in Chemistry, Biochemistry, Microbiology or Biotechnology.
• Experi
📌 QC Executive – Diagnostics Reagents (Hyderabad)
🏢 Arni Medica
📍 Hyderabad