Production & Packing Head

Industry : Pharmaceutical Manufacturing (High Regulatory Plant - USFDA, MHRA, EU-GMP, WHO-GMP, PIC/S)

Reporting To : Senior General Manager - Site Operations

Location : Amneal Matoda

Position Summary :

The General Manager - Production & Packing Head is responsible for end-to-end manufacturing and packaging operations of the pharmaceutical site, ensuring compliance with global regulatory requirements, safety standards, quality systems, and business objectives. The role leads production, packaging, manpower, productivity improvement, capacity utilization, operational excellence, and audit readiness while supporting the Senior General Manager in achieving overall site operational targets.

The person will be accountable for delivering production plans, maintaining regulatory compliance, driving continuous improvement, optimizing cost and productivity, and developing high-performing teams.

Key Responsibilities:

Manufacturing & Packaging Operations:

- Lead all Production and Packing operations across dosage forms (Tablets, Capsules, etc. as applicable).

- Ensure timely execution of manufacturing and packaging schedules to meet customer demand and business commitments.

- Drive overall plant performance through optimized capacity utilization and improved operational efficiency.

- Monitor daily production metrics, batch completion, yield, cycle times, and adherence to production plans.

- Ensure smooth coordination with QA, QC, Warehouse, Engineering, Supply Chain, and Regulatory Affairs.

Regulatory Compliance & Quality Systems:

- Ensure compliance with USFDA, MHRA, EU-GMP, TGA, WHO-GMP, and local regulatory requirements.

- Maintain inspection readiness at all times.

- Lead and support regulatory inspections and customer audits.

- Ensure adherence to cGMP, GDP, Data Integrity, ALCOA+ principles, SOPs, and quality systems.

- Drive closure of audit observations, CAPAs, deviations, change controls, investigations, and risk assessments.

Operational Excellence:

- Drive Lean Manufacturing, Six Sigma, Kaizen, TPM, and Operational Excellence initiatives.

- Improve OEE, throughput, productivity, and manufacturing cost efficiency.

- Identify bottlenecks and implement process improvements.

- Lead digitalization and manufacturing excellence projects.

Safety, Health & Environment (EHS):

- Ensure compliance with EHS policies and statutory requirements.

- Promote a culture of safety-first and zero-harm incidents.

- Participate in site safety reviews and risk mitigation programs.

- Lead incident investigations and preventive actions.

Resource & People Management:

- Lead and mentor production and packing teams, including managers, supervisors, and operators.

- Develop succession planning and talent pipeline for critical positions.

- Conduct performance reviews and capability-building initiatives.

- Foster a high-performance and compliance-driven culture.

Planning & Inventory Management:

- Collaborate with Supply Chain for production planning and execution.

- Ensure optimum utilization of manpower, equipment, and materials.

- Monitor inventory levels, material consumption, and production variances.

- Improve schedule adherence and reduce manufacturing lead time.

Cost Management:

- Drive cost-saving initiatives without compromising quality and compliance.

- Monitor manufacturing costs, wastage, yield losses, overtime, and productivity metrics.

- Prepare and manage departmental budgets.

Stakeholder Management:

- Work closely with Site Leadership Team to achieve business objectives.

- Support Senior General Manager in site operational reviews and strategic initiatives.

- Present operational performance during management review meetings.

Key Performance Indicators (KPIs) :

- Production Plan Adherence (%)

- Batch Release Performance

- OEE Improvement

- Capacity Utilization (%)

- Right First Time (RFT)

- Yield Improvement (%)

- Regulatory Audit Readiness

- Deviation & CAPA Closure Timeliness

- Cost per Batch/Product

- Productivity Improvement

- Inventory Optimization

- Safety Performance (Zero LTI)

- Employee Engagement & Retention

Qualifications:

Education:

- B.Pharm / M.Pharm / B.Tech / M.Sc. or equivalent.

- MBA Operations preferred.

Experience:

- 18-25 years of pharmaceutical manufacturing experience.

- Minimum 8-10 years in senior leadership roles managing Production and Packing operations.

- Strong experience in highly regulated facilities approved by USFDA, MHRA, EU, TGA, etc.

- Experience handling multiple successful regulatory inspections.

Required Competencies:

Technical Competencies:

- Pharmaceutical Manufacturing Operations

- Packaging Operations

- cGMP Compliance

- Data Integrity

- Regulatory Inspection Management

- Lean Manufacturing & Six Sigma

- Quality Systems

- Capacity Planning

- Manufacturing Excellence

- Budget Management

Leadership Competencies:

- Strategic Thinking

- Team Leadership

- Change Management

- Decision Making

- Stakeholder Management

- Problem Solving

- Conflict Resolution

- Coaching & Mentoring

Authority Matrix :

The GM - Production & Packing Head shall have authority to:

- Approve production execution plans.

- Allocate manufacturing resources and manpower.

- Escalate critical quality, compliance, and operational issues to the Senior General Manager.

- Lead operational reviews and manufacturing governance meetings.

- Recommend capital expenditure and process improvement projects.

Career Level :

Senior Leadership Position (Site Leadership Team Member)

This role serves as a key operational leader and acts as the second line of leadership under the Senior General Manager for ensuring efficient, compliant, and cost-effective site manufacturing and packaging operations.