Factory Production & Operations Manager – Medical Devices Manufacturing (DRAP Compliance)

Position Overview

The Factory Production & Operations Manager is responsible for end-to-end management of production and operational activities at a medical devices manufacturing facility (bandages, masks, medical tapes, and related disposables). The role ensures that production targets are achieved efficiently while maintaining strict compliance with Drug Regulatory Authority of Pakistan (DRAP) Medical Device Rules 2017, Good Manufacturing Practices for Medical Devices (GDPMD), and ISO 13485 standards. This position oversees production planning, workforce management, equipment utilization, maintenance, safety, and operational KPIs.

Key Responsibilities

1. Production Planning & Execution

• Develop and manage weekly/monthly production schedules aligned with sales forecasts.
• Monitor Planned vs. Actual Production and initiate corrective actions when targets are not met.
• Ensure efficient use of manpower, machines, and raw materials to maximize productivity.
• Maintain material wastage at ≤1% of total usage through process control and lean practices.

2. Operations & Process Management

• Oversee end-to-end factory operations including production, utilities, and support functions.
• Ensure manufacturing processes adhere to DRAP Medical Device Rules 2017 and ISO 13485 QMS requirements.
• Maintain safe, clean, and compliant production environments, including sterilization and hygiene protocols where applicable.

3. Equipment & Maintenance

• Collaborate with Maintenance teams to execute preventive and corrective maintenance plans.
• Monitor Maintenance Plan vs. Actual compliance and reduce downtime.
• Track Mean Time to Repair (MTR) for critical machines (mask machines, adhesive coaters, bandage cutters, wrapping units, etc.).
• Ensure calibration and validation of production equipment in compliance with regulatory requirements.

4. Workforce Management & Training

• Supervise production supervisors, line operators, and support staff.
• Train teams on GDPMD, ISO 13485, safety practices, and SOPs.
• Promote accountability, discipline, and teamwork across all factory staff.

5. Health, Safety & Risk Management

• Drive a Zero Total Recordable Incident Rate (TRIR) and maximize safe man-hours.
• Implement strict compliance with Occupational Health & Safety (OHS) standards.
• Conduct regular risk assessments, safety audits, and incident investigations.

6. Quality & Compliance Coordination

• Work closely with QA/QC Head to ensure in-process quality checks are followed.
• Ensure only QA-approved lots proceed to the next production stage.
• Support DRAP inspections and ISO audits with complete operational documentation.

7. Continuous Improvement & Reporting

1. Track, analyze, and report operational KPIs:

• Planned vs. Actual Production
• Material Wastage ≤1%
• Zero TRIR & Safe Man-Hours
• Maintenance Plan vs. Actual
• Mean Time to Repair (MTR)
• Process Downtime vs. Productivity

2. Recommend and implement process improvements for higher efficiency, reduced wastage, and stronger compliance.

Education & Experience Requirements

• Bachelor’s degree in Industrial/Manufacturing/Mechanical Engineering, Pharmacy, or related field (Master’s preferred).
• 7–10 years of experience in manufacturing management (medical devices, pharmaceuticals, or FMCG) with at least 3 years in a senior production/operations leadership role.
• Strong knowledge of DRAP Medical Device Rules 2017, GDPMD, and ISO 13485.
• Proven track record of production efficiency, KPI achievement, and compliance-driven operations.

Key Skills & Competencies

• End-to-end factory production and operations management expertise.
• Strong leadership and people management skills.
• Proficiency in KPI tracking, process optimization, and lean manufacturing.
• Familiarity with regulatory compliance (DRAP, GDPMD, ISO 13485).
• Excellent coordination with cross-functional teams (QA/QC, Maintenance, Procurement, Logistics).
• Analytical and problem-solving mindset.

Job Type: Full-time

Pay: Rs200,000.00 - Rs250,000.00 per month

Work Location: In person