Quality Manager

APSN Lifescience Sdn Bhd; Nilai; On-site; MYR 180,000 - 260,000; Full time

Benefits offered by this job

Performance Bonus

EPF top-up

Insurance (life/PI/medical)

Holidays

Training & development

Job summary

APSN Lifescience Sdn Bhd in Nilai and Petaling Jaya is seeking a dynamic Quality Manager to lead QA/QC within our GMP manufacturing operations. The role focuses on regulatory compliance, continuous improvement and building a strong GMP culture across manufacturing sites.

You will drive QMS, risk assessment, audits and product release, while collaborating with production, engineering and maintenance to resolve quality issues.

Qualifications

• Bachelor’s degree in a related field.
• Minimum 5 years QA/QC experience in a GMP manufacturing environment.
• Strong knowledge of GMP and Quality Management Systems.
• Hands-on experience with Deviation & CAPA, Change Control, Validation & qualification, internal/external audits, quality documentation and product release.
• Knowledge of PIC/S GMP and FAMI-QS is an advantage.

Responsibilities

• Lead and manage the QA and QC functions within the GMP facility.
• Ensure products, processes, raw materials and finished products meet quality and regulatory requirements.
• Oversee IPQC activities for in-process inspection, sampling, testing and quality monitoring.
• Review and approve quality-related procedures, specifications, test methods and records.
• Lead the QA/QC team and drive GMP culture across the organisation.
• Establish and maintain the Quality Management System (QMS) and ensure regulatory compliance.
• Lead audits, vendor qualification, training and continuous improvement initiatives.

Skills

QA/QC leadership

GMP knowledge

Regulatory compliance

Quality management systems

Problem-solving

Cross-functional collaboration

Communication

Education

Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, Life Sciences or related field

Tools

CAPA system

Change control system

Document control system

Vendor qualification system

Job description

In line with our continued business expansion, we are looking for a dynamic and experienced Quality Manager to join our growing team.

The Quality Manager will lead our Quality Assurance (QA) and Quality Control (QC) functions across our GMP manufacturing operations in Nilai and Petaling Jaya.

This is a key leadership opportunity for a quality-driven professional who is passionate about regulatory compliance, continuous improvement, and developing a strong GMP culture across a manufacturing environment.

What You'll Be Responsible For

1. Quality Assurance and Quality Control

Lead and manage the QA and QC functions and day-to-day quality activities within the GMP facility.

Ensure products, processes, raw materials and finished products meet established quality and regulatory requirements.

Lead and oversee IPQC activities to ensure effective in-process inspection, sampling, testing, and quality monitoring throughout the manufacturing process in compliance with GMP requirements.

Review and approve quality-related procedures, specifications, test methods and records.

Oversee the approval/rejection and release of raw materials, packaging materials and finished products.

2. GMP, Quality and Feed Safety Management System

Establish, implement, maintain and continuously improve the Quality Management System (QMS) in compliance with applicable GMP, quality and feed safety requirements.

Lead and oversee risk management activities, including Risk and Opportunities Assessment, Quality Risk Assessment, HACCP, VACCP and TACCP, to identify, evaluate and mitigate quality, food/feed safety and operational risks.

Lead and oversee Product Quality Reviews (PQR) to monitor product quality, process performance and compliance with established specifications and GMP requirements.

Ensure compliance with PIC/S GMP, FAMI-QS, applicable ISO standards and relevant regulatory requirements.

Manage and ensure effective implementation of key quality systems, including:

Deviation and investigation

Corrective and Preventive Action (CAPA)

Change Control

Product complaints

Product traceability and recall readiness

Document control

Supplier qualification and monitoring

Contract laboratory and outsourced GMP activities

Ensure GMP standards are consistently maintained across manufacturing operations, personnel hygiene, environmental controls, storage and quality documentation.

3. Validation and Compliance

Ensure compliance with applicable government regulations and GMP requirements, and support the Compliance/Regulatory Manager in maintaining the company’s regulatory compliance.

Lead and maintain the Validation Master Plan (VMP).

Oversee qualification and validation of facilities, utilities, equipment and processes.

Lead internal audits and vendor qualification audits.

Support regulatory inspections, customer audits and external audits.

Ensure audit findings, deviations and CAPAs are properly investigated and closed within the required timeframe.

Lead, coach and develop the QA/QC team.

Ensure appropriate GMP and quality training is provided to employees.

Work closely with Production, Engineering/Maintenance, Warehouse and other departments to resolve quality issues.

Promote a strong GMP and quality culture throughout the organisation.

Drive continuous improvement initiatives to strengthen quality and compliance.

What We're Looking For

Bachelor’s Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, Food Science, Life Sciences or a related field.

Minimum 5 years of relevant QA/QC experience, preferably in a GMP-regulated manufacturing environment.

Strong practical knowledge of GMP and Quality Management Systems.

Hands‑on experience in QA/QC operations, Deviation & CAPA, Change Control, Validation & qualification, Internal/external audits, Quality documentation, Product release etc.

Knowledge of PIC/S GMP and FAMI-QS will be an added advantage.

Experience in regulatory inspections, customer audits or supplier audits is highly desirable.

Strong leadership, analytical, problem-solving and decision‑making skills.

Good communication and interpersonal skills with the ability to work cross‑functionally.

Basic salary (depends on knowledge, experience & exposure)

5-days work week

• Performance Bonus
• Additional employer EPF contribution
• Insurance (Term life, Personal Accident & medical)
• Observe all gazetted holidays
• Training, Career Advancement & Personal Development Policy