Executive, Manufacturing Compliance & Operational Excellence (Sterile Facility)

Duopharma Biotech Bhd Group of Companies.; George Town; On-site; MYR 120,000 - 180,000; Full time

Job summary

Duopharma Biotech Berhad is seeking an Executive for Manufacturing Compliance & Operational Excellence (Sterile Facility) to drive GMP compliance, continuous improvement, and digitalisation across our sterile manufacturing operations. The role collaborates with Production, Quality, Engineering, and Planning to strengthen audit readiness and operational performance.

The ideal candidate has a 3+ year track record in regulated pharma manufacturing, with hands-on experience in deviations, CAPA, RCA,

Qualifications

• Bachelor's degree in Pharmaceutical Technology, Pharmaceutical Science, Chemical/Industrial/Mechanical Engineering or related field.
• Minimum 3 years in pharmaceutical manufacturing or highly regulated FMCG environments.
• Experience with ISO 9001, PIC/S GMP and regulatory audits.
• Experience handling Deviations, CAPA, RCA and risk assessments.
• Exposure to cleanroom operations and data-driven problem solving.

Responsibilities

• Drive PIC/S GMP/ISO compliance across manufacturing operations.
• Identify and close compliance gaps across Production, Engineering, Warehouse and Planning.
• Maintain audit readiness for NPRA, TGA, ISO and other inspections.
• Lead process improvement, Lean, 5S, Kaizen and digitalisation efforts.
• Review deviations, CAPA, RCA, risk assessments, SOPs and validation reports.
• Develop GMP training programs and promote a proactive culture of compliance.

Skills

GMP compliance

Regulatory audits

Data analysis

Excel

Process improvement

Lean manufacturing

Cross-functional collaboration

Documentation control

Education

Bachelor's degree in related field

Job description

Executive, Manufacturing Compliance & Operational Excellence (Sterile Facility)

Job Summary

We are looking for a proactive and analytical professional to drive manufacturing compliance, operational excellence, and continuous improvement initiatives across our manufacturing operations. This role will work closely with Production, Engineering, Warehouse, Planning, Quality, and other functions to strengthen GMP compliance, improve operational efficiency, support digitalisation, and maintain a permanent audit-ready environment.

Key Responsibilities

Manufacturing Compliance & Regulatory Readiness

Drive compliance with PIC/S GMP, including PIC/S Annex 1, ISO 9001, and ISO 13485 requirements across manufacturing operations.

Identify, assess, and close compliance gaps across Production, Engineering, Warehouse, and Planning.

Support manufacturing sites in maintaining audit readiness for NPRA, TGA, ISO, and other regulatory inspections.

Drive timely and effective CAPA closure and support investigation of compliance issues.

Operational Excellence & Continuous Improvement

Lead process improvement initiatives to enhance manufacturing efficiency and operational performance.

Promote Lean manufacturing, 5S, Kaizen, and shopfloor improvement practices.

Identify and eliminate manual, repetitive, and redundant workflows.

Drive digitalisation, automation, Industry 4.0, and system improvement initiatives across manufacturing.

Quality Systems & Technical Governance

Review and oversee deviations, CAPA, root cause investigations, risk assessments, protocols, validation reports, SOPs, and other technical documentation.

Ensure manufacturing documentation is clear, traceable, accurate, and compliant with Data Integrity principles.

Apply data analysis and trend monitoring to identify potential compliance and operational risks.

Support systematic root cause analysis and long-term corrective actions.

Training & GMP Culture

Develop and maintain GMP training programmes for manufacturing personnel.

Identify training needs and ensure employees are trained, assessed, and qualified before deployment in GMP areas.

Conduct shopfloor engagements and walkabouts with operators, supervisors, and management.

Promote a proactive culture of GMP compliance, risk awareness, and continuous improvement.

Project & Stakeholder Management

Lead cross-functional compliance and operational improvement projects from planning through implementation.

Ensure projects are delivered according to agreed timelines, scope, and requirements.

Act as a compliance advisor for Manufacturing projects, particularly in risk assessment and contamination control.

Work closely with Production, Quality, Engineering/Maintenance, Warehouse, Planning, HR, and other stakeholders to drive improvements.

Requirements

Qualifications

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

Experience

Minimum 3 years of experience in pharmaceutical manufacturing, medical devices, hygiene, or a highly regulated FMCG environment.

Experience in manufacturing compliance, process improvement, engineering projects, or compliance gap closure.

Process Engineers with relevant manufacturing experience are encouraged to apply.

Technical Skills & Knowledge

Hands-on experience in an ISO 9001 manufacturing environment with exposure to regulatory audits.

Working knowledge of PIC/S GMP and manufacturing compliance requirements.

Experience managing or reviewing Deviations, CAPA, Root Cause Analysis (RCA), and risk assessments.

Familiarity with cleanroom operations.

Strong technical writing skills, including SOPs, protocols, validation reports, and technical documentation.

Proficient in Microsoft Excel, including Pivot Tables, VLOOKUP, dashboarding, data analysis, and trend identification.

Experience with data-driven problem solving and statistical analysis.

Exposure to Lean Manufacturing, 5S, or Kaizen will be an added advantage.

Strong analytical and problem-solving abilities.

Data-driven approach to identifying trends, risks, and improvement opportunities.

Strong project management and execution skills.

Excellent communication and stakeholder management skills.

Able to engage effectively with operators, supervisors, executives, and senior stakeholders.

Proactive mindset with strong ownership and accountability.

Comfortable adopting digital tools and driving technology-enabled improvements.

Why Join Us?

Drive meaningful improvements across pharmaceutical manufacturing operations.

Gain exposure to GMP, PIC/S Annex 1, ISO standards, regulatory audits, and manufacturing compliance.

Lead cross-functional operational excellence and digitalisation initiatives.

Work closely with Production, Quality, Engineering, Warehouse, Planning, and other key functions.

Develop expertise across compliance, data analytics, Lean manufacturing, and operational excellence.

Duopharma Biotech Berhad began with the establishment of Duopharma (M) Sdn Bhd in 1978. Incorporated in 2000, we are one of Malaysia’s leading pharmaceutical companies listed on the Bursa Malaysia’s Main Market. We specialise in manufacturing, R&D, and marketing of generic drugs and consumer healthcare products (CHAMPS®, FLAVETTES® & UPHAMOL) as well as biosimilars (ERYSAA®, Basalog One®). As a pioneer in halal pharmaceuticals, we were the 1st to receive JAKIM certification for OTC and prescription products under MS2424:2019. Headquartered in Kuala Lumpur, we operate three GMP-certified plants (Klang, Bangi & Glenmarie) and have a growing presence in Indonesia, the Philippines and Singapore.