GMP Quality & Compliance Lead (QA/QC)

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

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.