The role requires a seasoned professional with strong experience in medical device manufacturing, regulatory compliance, plant administration, and operational leadership.

The candidate will be responsible for managing all government regulatory matters independently, supervising production of wound care products, bandaging materials, orthopaedic soft goods, and surgical blades, and upgrading the facility to global manufacturing standards with optimal efficiency and cost control.

Key Responsibilities:

Factory Administration:

- Overall administration and operational supervision of Unit 1 and Unit 2 at Palghar

- Liaison and coordination with Government authorities including regulatory bodies

- Ensuring compliance with all statutory and regulatory requirements applicable to medical device manufacturing

Manufacturing Operations

Supervise production of:

- Wound Care Products

- Bandaging Materials

- Orthopedic Soft Goods

- Surgical Blades

- Ensure efficient production planning and scheduling

- Improve plant productivity, efficiency and cost optimization

- Implement modern manufacturing practices and process improvements

Regulatory Compliance

Ensure full compliance with:

- Medical Devices Rules, 2017

- Regulations of the Central Drugs Standard Control Organization

- Global regulatory frameworks including CE / EU MDR and US FDA QSR (21 CFR Part 820) where applicable.

Quality & Systems Management

Ensure adherence to international quality standards including:

- ISO 13485

- ISO 14971

- Good Manufacturing Practices (GMP)

Ensure proper implementation of:

- Process validation

- Equipment qualification

- Cleaning validation

- CAPA and deviation management

Technical Oversight

- Supervise device manufacturing processes

Ensure compliance with sterilization technologies such as:

- ETO Sterilization

- Gamma Sterilization

- Steam Sterilization

Documentation & Compliance

Ensure proper maintenance of:

- Device Master Records (DMR)

- Device History Records (DHR)

- Batch Manufacturing Records

- Standard Operating Procedures (SOPs)

Experience Requirements

- Minimum 10-15 years of proven experience in factory administration and manufacturing operations, preferably in medical devices or healthcare manufacturing.

Education: BE Mechanical or equivalent engineering or B. SC/ M. Sc / B. Pharma/ M. Pharma