QC EXECUTIVE

Astam Diagnostics Pvt LTD In Vitro Diagnostics (IVD) & Medical Devices (MD) Plant

Department

Quality Control

Reports To

QC Team Lead / QC Manager

Location

Manufacturing Plant

Employment Type

Full-Time, Permanent

Regulatory Scope

IVD (IVDR / CDSCO MD Rules) & Medical Devices (MDR / ISO 13485)

Experience Required

3–6 years in QC in IVD or Medical Device manufacturing

Education

B.Sc. / M.Sc. / B.Tech in relevant discipline; additional QMS certifications preferred

Salary

30-40K negotiable

Role SummaryThe QC Executive is a hands-on technical role responsible for executing day-to-day quality control activities across raw material, in-process, and finished product testing at the IVD and Medical Devices manufacturing plant. The incumbent will ensure testing is performed accurately and in accordance with approved SOPs, regulatory requirements (ISO 13485, CDSCO MD Rules 2017), and internal quality standards, supporting the delivery of secure and compliant products.

Key Responsibilities1. Testing & Analysis

• Perform physical, chemical, microbiological, and functional testing of raw materials, in-process samples, and finished products as per approved specifications and SOPs.

• Execute ELISA, PCR/qPCR, immunoassay, colorimetry, spectrophotometry, and microbiological assays for IVD product testing.

• Operate and maintain laboratory instruments including spectrophotometers, plate readers, PCR machines, pH meters, and analytical balances.

• Record all test data accurately in laboratory notebooks, worksheets, and LIMS/ERP systems in real time.

• Ensure proper labelling, storage, and traceability of test samples, reference standards, and reagents.

2. Documentation & Compliance

• Prepare and review test reports, Certificates of Analysis (CoAs), and batch release documentation.

• Follow and maintain Good Documentation Practices (GDP) at all times.

• Maintain up-to-date laboratory records including calibration logs, equipment usage logs, and sample registers.

• Adhere to applicable quality standards including ISO 13485:2016, CDSCO Medical Device Rules 2017, and NABL ISO 17025 requirements.

• Identify and report Out-of-Specification (OOS) and Out-of-Trend (OOT) results promptly to the QC Manager.

3. Equipment & Laboratory Upkeep

• Perform routine calibration checks and preventive maintenance of assigned laboratory instruments.

• Maintain equipment logbooks and escalate any equipment failures or abnormalities for corrective action.





• Ensure proper handling, storage, and disposal of chemicals and biological samples as per safety and regulatory guidelines.

• Support qualification activities (IQ/OQ/PQ) for laboratory equipment as directed.

4. CAPA & Quality Systems

• Identify, document, and report non-conformances, deviations, and quality events arising from day-to-day QC activities.

• Participate actively in root cause analysis (RCA) for QC-related failures using structured tools such as 5-Why, Fishbone (Ishikawa), and brainstorming techniques.

• Raise Corrective Action and Preventive Action (CAPA) records in the QMS for QC deviations, OOS/OOT results, and equipment failures.

• Implement assigned CAPA actions within defined timelines and maintain evidence of completion.

• Conduct effectiveness checks for closed CAPAs to verify the root cause has been adequately addressed and recurrence prevented.

• Monitor QC data trends (failure rates, OOS frequency, instrument downtime) and escalate adverse trends to the QC Manager for proactive CAPA initiation.

• Support internal and external quality audits, including preparation of records, evidence packs, and on-floor readiness.

• Contribute to preparation and periodic revision of SOPs, test methods, work instructions, and associated forms.

5. Raw Material & Supplier Quality

• Conduct incoming quality inspection and testing of raw materials and components against approved acceptance criteria.

• Review supplier Certificates of Analysis (CoAs) and flag discrepancies for escalation.

• Maintain and update the approved vendor material inventory for QC reference.

6. Method Development Support

• Assist in analytical method validation studies under the guidance of senior QC personnel or the QC Manager.

• Participate in stability studies (real-time and accelerated) for IVD reagents and medical device components.

• Support new product introduction by performing qualification testing and contributing to DHF documentation.

Qualifications & ExperienceEssential

• B.Sc. / M.Sc. in Biochemistry, Microbiology, Life Sciences, Biotechnology, or related discipline; or B.Tech/B.E.



in Biomedical Engineering or equivalent.

• 3–6 years of hands-on experience in a QC role in an IVD, medical device, diagnostics, or pharmaceutical manufacturing environment.

• Practical knowledge of laboratory techniques: ELISA, PCR, spectrophotometry, microbiological testing, and basic chemistry assays.

• Familiarity with ISO 13485 QMS requirements and GMP/GDP practices.

• Proficiency in maintaining laboratory documentation and using LIMS or ERP-based systems.

• Good understanding of calibration, preventive maintenance, and equipment qualification practices.

Preferred

• Experience in a NABL-accredited laboratory (ISO 17025).

• Exposure to CDSCO Medical Device Rules 2017 and CE marking documentation requirements.

• Basic knowledge of statistical tools for QC data analysis: control charts, trend analysis, and acceptance sampling.

• Familiarity with OOS/OOT investigation processes and CAPA management.

• Certification in internal quality auditing or any relevant QMS training programme.

Key CompetenciesTechnical Competencies

Behavioural Competencies

IVD / MD testing techniques

Attention to detail & accuracy

Laboratory instrumentation & upkeep

Compliance & ethical conduct

Regulatory & GMP knowledge

Team collaboration & communication

GDP & documentation practices

Problem-solving & analytical thinking

OOS/OOT identification & escalation

Initiative & continuous learning

CAPA management & RCA tools

Accountability & ownership

LIMS / ERP data entry & management

Time management & prioritisation

Key InterfacesInternal

External

QC Manager & QC Team Lead

NABL Assessment Bodies (during audits)

Quality Assurance & Regulatory Affairs

Raw material & component suppliers

Manufacturing / Production team

Third-party contract laboratories

Engineering & Maintenance

Equipment calibration service providers

R&D; / New Product Development

Applicable Regulatory Frameworks• CDSCO Medical Device Rules, 2017 (India)

- ISO 13485:2016 — Quality Management Systems for Medical Devices
- ISO 17025:2017 — General requirements for testing and calibration laboratories (NABL)
- EU IVDR (Regulation 2017/746) & EU MDR (Regulation 2017/745) — as applicable
- ISO 14971:2019 — Application of risk management to medical devices
- ISO 10993 series — Biological evaluation of medical devices
- Relevant BIS / IS standards for IVD and medical devices

- Confidential | Internal Us

📌 Quality Control Executive (New Delhi)
🏢 Astam Diagno
📍 New Delhi