QA / QC Executive

Required Qualification

• B.Pharm / M.Pharm / B.Sc. / M.Sc. in Chemistry, Microbiology, Biotechnology, Life Sciences, or related discipline.
• Candidates with qualifications relevant to medical device quality management may also be considered.

Experience

• Fresher to 3 years of experience in Quality Control / Quality Assurance.
• Experience in medical devices, surgical sutures, pharmaceuticals, or sterile manufacturing will be preferred.

Required Skills

• Basic knowledge of ISO 13485 and medical device Quality Management Systems.
• Knowledge of Good Manufacturing Practices and Good Documentation Practices.
• Understanding of QC testing, inspection, sampling, and product release procedures.
• Basic knowledge of CAPA, deviation handling, change control, risk management, and internal audits.
• Good documentation and record-maintenance skills.
• Proficiency in MS Word and Excel.
• Good communication and coordination skills.
• Attention to detail and ability to identify quality-related issues.

Preferred Knowledge

• ISO 13485:2016
• Medical Devices Rules, 2017
• Sterile medical device manufacturing
• EO sterilization
• Cleanroom practices and environmental monitoring
• Sterility and microbiological testing
• Equipment qualification and process validation
• Risk management as per ISO 14971
• Surgical suture testing and specifications

Key Performance Indicators

• Timely completion of QC testing and product release.
• Accuracy and completeness of quality documentation.
• Timely closure of CAPA, deviations, and non-conformances.
• Compliance with SOPs and regulatory requirements.
• Audit performance and closure of audit observations.
• Reduction in quality defects and documentation errors.