Full Time Head of Production, Hanan Manufacturing Jobs, Salary up to MYR 15,000 in Kenanga Network Selangor - Maukerja

KEY ACCOUNTABILITIES:

1. Production Leadership and Key Personnel Responsibility

• Serve as the site’s designated Head of Production, accountable for ensuring products are produced and stored according to approved instructions to obtain the required quality.
• Lead a single, unified Production department covering both sterile operations (Biological Drug Product, Small Volume Parenteral) and non-sterile operations (Solution for Inhalation), setting priorities and resolving resource conflicts across all lines.
• Approve production instructions, including Master Batch Records and in-process controls, and ensure their strict implementation on the shop floor.
• Ensure batch production records are evaluated and signed by an authorised person before submission to QA, while maintaining independence from QA and QC as required of key personnel; batch certification remains with the Authorised Person.

2. Facility Start-Up and Operational Readiness

• Lead production readiness for the greenfield facility in line with the commissioning, aseptic process simulation and NPRA inspection timeline.
• Define production user requirements and participate in design reviews and DQ, FAT, SAT, IQ, OQ and PQ of process equipment, isolators/RABS, filling lines and production-critical utilities.
• Build the production operating model: shift patterns, line ownership, room and equipment status controls, cleaning regimes and batch documentation flows.
• Maintain the production readiness plan (SOPs, Master Batch Records, training, equipment, materials), report status to the Head of Plant and escalate risks to licensing milestones with mitigation proposals.

3. Technology Transfer and Process Validation

• Own receipt of manufacturing processes from licensors and technology partners, including process knowledge transfer, gap assessment and equipment/scale fit.
• Co-author and execute trial runs, performance qualification, process validation and cleaning validation with Technical Service (validation execution) under QA approval.
• Ensure critical process parameters and in-process controls are translated accurately into Master Batch Records and operating SOPs.
• Support continued process verification once commercial production begins, confirming the process remains in a state of control in line with PIC/S Annex 15.

4. Aseptic Processing and Contamination Control

• Own aseptic operations in compliance with PIC/S GMP Annex 1, including gowning, aseptic technique, interventions, line clearance and cleanroom behaviour.
• Co-own the site Contamination Control Strategy with QA, Technical Service and Engineering, and ensure production practice remains aligned with it.
• Plan and lead aseptic process simulations (media fills), including worst-case intervention design, operator participation and periodic requalification.
• Manage aseptic operator qualification, requalification and disqualification, and respond promptly to environmental monitoring excursions and sterility assurance signals.

5. GMP Compliance, Documentation and Data Integrity

• Ensure all production SOPs, work instructions and batch records are current, approved and followed.
• Own production deviations, investigations, CAPA and change control initiation within agreed timelines, applying structured root-cause analysis and ICH Q9 risk principles.
• Uphold ALCOA+ data integrity for paper and electronic production records in line with PIC/S PI 041 and Annex 11 for computerised systems.
• Contribute production inputs to internal audits, Management Review and Product Quality Reviews under the site Pharmaceutical Quality System (ICH Q10).

6. Inspection Readiness and Regulatory Interface

• Prepare the production function for NPRA licensing inspections, PIC/S-standard inspections, partner audits and customer audits.
• Act as the production spokesperson during inspections, presenting processes, records and controls accurately and confidently.
• Ensure timely, effective closure of production-related inspection observations and audit findings.
• Provide accurate manufacturing process information for site master files and product registration dossiers.

7. Production Planning and Operational Performance

• Translate the supply plan from Supply Chain Management into a feasible production schedule across all lines and campaigns.
• Coordinate material staging with SCM and the outsourced warehousing and cold chain provider to protect schedule adherence and product integrity.
• Define, track and report production KPIs — schedule adherence, right-first-time batch records, yield, OEE, deviation rate and batch cycle time.
• Lead daily and weekly performance reviews, manage capacity, changeovers and campaign sequencing, and protect the Division’s commercial supply commitments.

8. Occupational Safety, Health and Cross-Contamination Control

• Ensure hazardous materials used in production — including volatile liquids, cleaning and sanitising agents — are handled in line with approved occupational exposure controls, PPE requirements, and spill and decontamination procedures.
• Maintain segregation and cross-contamination controls between sterile and non-sterile operations and across product streams, in line with the site’s risk-based cross-contamination assessment.
• Ensure production areas comply with the Occupational Safety and Health Act 1994.
• Promote a strong safety culture in which incidents and near misses are reported, investigated and acted upon.

9. Leadership, Capability Building and Resource Management

• Recruit, onboard and build the Production department in line with the approved organization chart and recruitment schedule.
• Define production training curricula with HR and QA, and ensure personnel are trained and qualified before performing GMP activities.
• Lead, coach and develop section leads and executives; set departmental objectives, conduct performance reviews and maintain succession plans.
• Foster a culture of ownership, discipline and continuous technical learning appropriate to a sterile manufacturing site.

10. Budget, Cost Control and Continuous Improvement

• Prepare and control the Production departmental budget and contribute to capital expenditure planning for production equipment.
• Optimise manpower, consumables and utilities usage without compromising GMP compliance or safety.
• Lead continuous improvement initiatives to improve efficiency, yield and right-first-time performance.
• Evaluate new technologies and process improvements and present business cases to the Head of Plant.

Pay: RM10,000.00 - RM15,000.00 per month

Benefits:

• Health insurance
• Opportunities for promotion
• Professional development

Application Question(s):

• Do you have any working experience in sterile pharmaceutical manufacturing? If yes, please specify the duration of your experience.
• What is your expected monthly salary for this position?
• Our office is located in Kundang, Rawang. Are you comfortable commuting to this location on a daily basis?

Work Location: In person