IPQA Executive

Job description

Position: IPQA Executive

Company: Boditech Med India Pvt. Ltd.

Location: Jhajjar, Haryana, INDIA

Experience: 1-2 Years

Salary: Not disclosed

Job description, roles and responsibilities:

Boditech Med India Pvt. Ltd., the wholly owned subsidiary of Boditech Med Inc., South Korea is seeking an Production Executive for its In Vitro Diagnostic (IVD) devices manufacturing factory in the Reliance Model Economic Township Industrial Area at Jhajjar in Haryana State.Role & responsibilities

Preferred candidate profile

. Job Purpose

To ensure compliance of in-process manufacturing activities with approved SOPs, Work Instructions, Batch Records, Quality Standards, and ISO 13485 requirements, and to support effective implementation of the Quality Management System on the shop floor.

2. Key Responsibilities

• Perform routine IPQA activities on the production floor and ensure compliance with approved procedures.
• Conduct line clearance before commencement of production/packing activities.
• Verify and monitor critical process parameters at defined stages of manufacturing.
• Ensure production activities are performed as per approved SOPs, Work Instructions, BMR/BPR, and specifications.
• Perform in-process checks and verification of production records.
• Verify identification, status, quantity, and traceability of raw materials, components, and packaging materials.
• Monitor environmental conditions such as temperature and relative humidity in controlled production areas, where applicable.
• Review and verify batch manufacturing and production documentation for completeness and accuracy.
• Identify and report deviations, non-conformities, process abnormalities, and documentation errors.
• Support investigation of deviations, non-conformities, and quality incidents, including Root Cause Analysis (RCA) and CAPA.
• Support implementation and effectiveness monitoring of CAPA actions.
• Participate in change control, risk assessment, validation, and qualification activities as required.
• Ensure proper implementation of Good Documentation Practices (GDP) on the shop floor.
• Monitor compliance with 5S, hygiene, housekeeping, and GMP requirements.
• Support investigation of customer complaints related to manufacturing/process issues.
• Coordinate with Production, QC, Engineering, Warehouse, and other departments for resolution of quality-related issues.
• Conduct routine quality awareness/training for production personnel when required.
• Prepare IPQA reports, checklists, and other quality records.
• Support internal, external, customer, and regulatory audits.
• Ensure compliance with ISO 13485, applicable regulatory requirements, and BDTI QMS procedures.

3. Qualification

• B.Sc./M.Sc./B Tech/M Tech in Biotechnology, Microbiology, Life Sciences, Chemistry, or related field.

4. Experience

• 12 years of experience in IPQA/QA in IVD, medical devices, diagnostics, pharmaceutical, or other regulated manufacturing industries.
• Fresh candidates with relevant internship/training may be considered based on technical knowledge and aptitude.

5. Required Skills

• Good understanding of Quality Assurance and QMS principles.
• Basic knowledge of ISO 13485 and GMP.
• Good understanding of SOPs, BMR/BPR, specifications, and quality documentation.
• Knowledge of GDP and data integrity principles.
• Basic knowledge of deviation, CAPA, change control, and RCA.
• Good observation and analytical skills.
• Good communication and coordination skills.
• Good working knowledge of MS Excel and MS Office.
• Ability to work effectively on the production floor and coordinate with cross-functional teams.

6. Preferred Skills

• Experience in IVD/medical-device manufacturing.
• Exposure to ISO 13485 audits and regulatory inspections.
• Knowledge of risk management and validation activities.
• Experience with ERP/SAP or electronic QMS.
• Knowledge of basic statistical tools and quality improvement techniques.

7. Key Performance Indicators (KPIs)

• Timely completion of IPQA checks and line clearances.
• Compliance with SOPs and approved manufacturing procedures.
• Accuracy and completeness of batch documentation.
• Timely identification and reporting of deviations/non-conformities.
• Effective follow-up of CAPA and corrective actions.
• Reduction in recurring process-related quality issues.
• Compliance with ISO 13485, GMP, GDP, and internal QMS requirements.
• Timely support during audits and inspections.