- Bachelor's or Diploma in Engineering, Biomedical Engineering, Biotechnology, Pharmacy etc.
Minimum Experience
- 8–12 years of QA/QC experience in Medical Device, Pharmaceutical, or Automobile Manufacturing Industry.
1. Key Accountabilities
- Support implementation and maintenance of the Quality Management System (QMS).
- Ensure compliance with ISO 13485, 21 CFR Part 820, applicable MDR requirements, and company procedures.
- Review and approve SOPs, work instructions, protocols, reports, and quality records.
- Manage CAPA, Change Control, Deviations, Non-conformance, Customer Complaints, and Risk Management activities.
- Review Batch Manufacturing Records (BMR) and support batch release activities.
- Coordinate Internal Audits and participate in supplier audits and external regulatory audits.
- Monitor quality KPIs and identify opportunities for continual improvement.
- Conduct root cause analysis and implement effective corrective and preventive actions.
- Coordinate validation documentation review (IQ/OQ/PQ, Process Validation, Cleaning Validation where applicable).
- Support supplier quality management including supplier qualification and performance monitoring.
- Provide QMS and regulatory training to employees.
- Participate in quality culture initiatives and continuous improvement projects.