Assistant Manager, Production (HAPI Manufacturing)

Assistant Manager, Production (HAPI Manufacturing)

Location: Glenmarie, Selangor
Company: Duopharma HAPI Sdn Bhd

Job Summary

We are seeking an experienced and hands-on Assistant Manager, Production to support and coordinate manufacturing operations at our Highly Active Pharmaceutical Ingredients (HAPI) manufacturing facility. The role is responsible for ensuring HAPI products are manufactured safely, efficiently, on schedule, and in full compliance with GMP, containment controls, regulatory requirements, and company standards.

The successful candidate will oversee production activities, lead production personnel, drive process improvement, and ensure a strong culture of quality, safety, and operational discipline within the manufacturing environment.

Key Responsibilities

Production Operations

• Plan, coordinate, and oversee daily HAPI manufacturing operations to achieve production schedules, targeted volumes, and quality requirements.
• Ensure manufacturing processes including dispensing, granulation, tableting, encapsulation, coating, washing, and packing are executed in accordance with approved procedures and specifications.
• Monitor production performance and identify opportunities to improve plant efficiency, productivity, and product quality.
• Ensure HAPI products are manufactured and stored according to approved documentation and requirements.
• Act as the Acting Head of Production in the absence of the Production HOD.

GMP, Containment & Regulatory Compliance

• Lead and monitor cGMP implementation within manufacturing facilities in accordance with written procedures and PIC/S GMP requirements.
• Ensure appropriate containment controls are implemented throughout HAPI manufacturing operations.
• Promote a strong culture of quality, safety, hygiene, and regulatory compliance among production personnel.
• Ensure production records are properly evaluated and signed by authorised personnel.
• Work closely with Quality and other functions to address compliance gaps and maintain manufacturing readiness.

People Management & Training

• Lead, supervise, motivate, and develop production personnel to achieve operational and quality objectives.
• Ensure employees receive appropriate GMP, containment control, safety, and SOP training before performing manufacturing activities.
• Ensure initial and continuing training programmes are implemented and updated according to operational needs.
• Foster a strong quality and safety culture within the production team.

Process Improvement & Problem Solving

• Lead and participate in root cause analysis, investigations, and process improvement initiatives to address manufacturing issues and compliance gaps.
• Identify opportunities to improve manufacturing processes, productivity, quality, and operational efficiency.
• Collaborate with cross-functional teams to develop and implement improved working methods and HAPI manufacturing processes.

Equipment, Validation & Facility Management

• Ensure required calibration of manufacturing plants, machinery, and instruments is completed according to schedule.
• Ensure appropriate validation activities are completed in accordance with requirements.
• Monitor hygiene, safety, housekeeping, and workplace conditions within manufacturing areas.
• Support the preparation of annual capital expenditure proposals relating to regulatory requirements, production needs, and facility upgrades.

Cross-Functional & External Stakeholder Management

• Establish effective working relationships with Production, Quality, Engineering, R&D, and other internal functions.
• Coordinate with vendors, auditors, and regulatory authorities when required.
• Support technology transfer and HAPI product development activities through effective communication and technical collaboration.

Requirements

Qualifications

• Bachelor's Degree in Science, Engineering, Pharmaceutical Science, Pharmaceutical Technology, Chemical Engineering, Mechanical Engineering, or a related discipline.

Experience

• Minimum 3–5 years of experience in pharmaceutical manufacturing.
• Experience in HAPI, high-potency pharmaceutical manufacturing, containment manufacturing, or regulated pharmaceutical production will be a strong advantage.
• Candidates with experience in production operations within a GMP-regulated environment are encouraged to apply.

Technical Skills & Knowledge

• Good knowledge of Good Manufacturing Practice (GMP), PIC/S guidelines, and pharmaceutical manufacturing processes.
• Knowledge of containment principles and occupational exposure limits/bands is an advantage.
• Understanding of manufacturing processes and production equipment.
• Experience in production documentation, validation, calibration, and GMP compliance.
• Strong problem-solving and root cause analysis capabilities.
• Good understanding of production planning, process improvement, and operational efficiency.

The original JD specifically identifies GMP, containment controls, PIC/S guidelines, pharmaceutical manufacturing, and containment principles as important technical knowledge areas.

Key Competencies

• Strong leadership and people management skills.
• Excellent planning and organisational abilities.
• Strong analytical and problem-solving skills.
• Good communication and presentation skills.
• Ability to coordinate multiple priorities and meet production deadlines.
• Strong interpersonal skills with the ability to work effectively with internal and external stakeholders.
• Proactive, flexible, and committed to continuous improvement.