Key Responsibilities
- Plan and execute daily production activities to meet delivery schedules.
- Supervise production operators and allocate manpower based on requirements.
- Ensure compliance with ISO 13485, FDA 21 CFR, GMP, and company SOPs.
- Monitor and record production data, batch records, and ensure traceability.
- Support validation activities (IQ, OQ, PQ) for equipment and processes.
- Conduct in-process quality checks and coordinate with QA for deviations, CAPA, and audits.
- Oversee machine setup, preventive maintenance, and ensure minimal downtime.
- Coordinate with the supply chain for raw material availability and consumption records.
- Drive continuous improvement initiatives.
- Maintain a safe and compliant work environment as per EHS standards.
Key Skills & Competencies
- Knowledge of medical device manufacturing processes (assembly, moulding, packaging, sterilisation).
- Strong understanding of regulatory requirements (ISO 13485, GMP, FDA 21 CFR).
- Good documentation, record-keeping skills.
- Strong leadership, problem-solving, and team coordination abilities.
- Ability to work under pressure with attention to detail and compliance.
Qualification & Experience
- Education: Diploma, I.T.I, B.Sc. / B.Pharm / B.Tech in Mechanical, Biomedical, Biotechnology, Pharmacy, or related discipline.
