The Manager – Production (FIA) will be responsible for leading the Fluorescence Immunoassay (FIA) Uncut Sheet manufacturing operations, ensuring production targets are achieved while maintaining the highest standards of quality, regulatory compliance, safety, and cost efficiency. The role involves managing production teams, driving continuous process improvements, coordinating with cross-functional departments, and ensuring adherence to ISO 13485, GMP, and Medical Device manufacturing requirements.

Key Responsibilities

Production Management

Plan, organize, and supervise daily FIA Uncut Sheet manufacturing activities.
Ensure achievement of production targets while maintaining quality standards.
Optimize manpower utilization and production scheduling.
Monitor production performance and improve productivity.

Team Leadership

Lead, mentor, and develop production supervisors and operators.
Build a high-performance production team.
Conduct skill development and technical training programs.
Drive employee engagement, discipline, and workplace safety.

Quality & Compliance

Ensure compliance with ISO 13485:2016, GMP, and applicable Medical Device regulations.
Maintain complete production documentation and batch records.
Support internal, customer, and regulatory audits.
Implement and monitor CAPA activities.

Validation & Documentation

Support equipment and process validation activities including:
IQ (Installation Qualification)
OQ (Operational Qualification)
PQ (Performance Qualification)
PV (Process Validation)
DQ (Design Qualification)
URS preparation and review
Review SOPs, BMRs, work instructions, and validation protocols.

Process Improvement

Identify production bottlenecks and implement corrective actions.
Reduce production waste and improve operational efficiency.
Analyze production data and implement Lean Manufacturing initiatives.
Improve OEE, yield, and production cycle time.

Equipment Management

Ensure proper operation and maintenance of production equipment.
Coordinate preventive and breakdown maintenance with Engineering.
Minimize equipment downtime.

Cross Functional Coordination

Work closely with:
Quality Assurance
Quality Control
R&D
Warehouse
Engineering
Planning
Supply Chain
Support new product introduction and technology transfer.

Inventory & Material Management

Plan raw material requirements.
Coordinate procurement planning.
Monitor material consumption and reduce wastage.

Reporting & MIS

Prepare daily, weekly, and monthly production reports.
Present production KPIs to senior management.
Monitor productivity, rejection, downtime, and efficiency.

Safety & Regulatory Compliance

Ensure compliance with EHS guidelines.
Promote safe working practices.
Ensure implementation of 5S and Good Manufacturing Practices.

Key Performance Indicators (KPIs)

Production Target Achievement (%)
Overall Equipment Effectiveness (OEE)
Batch Yield (%)
Right First Time (RFT)
Rejection Rate
Productivity per Employee
Machine Downtime
CAPA Closure
Audit Compliance Score
Documentation Accuracy
Material Wastage (%)
On-Time Production Completion
Training Compliance
Safety Incidents (Zero LTI Target)

Education

Bachelor's Degree in Biotechnology, Microbiology, Biochemistry, Biomedical Engineering, Mechanical Engineering, Industrial Engineering, Pharmacy, or a related discipline.
Master's Degree preferred (MBA Operations / M.Sc. / M.Tech. is an added advantage).

Experience

8–15 years of experience in Medical Device, IVD, Diagnostics, Biotechnology, or Healthcare Manufacturing.
Minimum 5 years in a leadership role managing FIA production or similar immunoassay manufacturing operations.
Hands-on experience in FIA Uncut Sheet manufacturing is highly preferred.

Technical Skills