Pharmaceutical Manufacturing Specialist

Comcorde Medical (M) Sdn Bhd; Kuala Lumpur; On-site; MYR 100,000 - 150,000; Full time

Job summary

A medical device manufacturing company in Kuala Lumpur is seeking a qualified individual to oversee daily production activities and ensure compliance with ISO standards. The ideal candidate holds a bachelor's degree in Pharmacy or related fields and possesses strong communication skills. Benefits include medical claims and compliance with Labour Law for annual and medical leave.

Benefits

KWSP

SOCSO

Medical claim included

Annual and medical leave as per Labour Law

Qualifications

• Solid understanding of ISO 13485 and medical device regulations.
• Licensed Pharmacist qualification is a strong advantage.
• Fluent in Bahasa Malaysia and English.

Responsibilities

• Oversee daily production activities in compliance with standards.
• Maintain NPRA's QUEST3+ online platform.
• Conduct training for production staff.

Skills

Strong communication

Teamwork skills

Education

Bachelor's degree in Pharmacy or related fields

Job description

Job Responsibility

• Oversee and supervise daily production activities in compliance with ISO 13485 and GMP standards;
• To maintain NPRA's QUEST3+ online platform
• To assists on Medical Device Regulations
• Review and manage production-related documentation, including SOPs and batch production records;
• Support equipment qualification, process validation, and cleanroom environmental monitoring;
• Participate in deviation handling, change control, CAPA, and other quality investigations;
• Assist with production planning and coordinate personnel and materials efficiently;
• Conduct training and assessments for production staff to enhance regulatory awareness;
• Collaborate closely with QA, R&D, and Regulatory departments to ensure product quality and safety.
  
  

Job Requirements

• Bachelor's degree or above in Pharmacy, Pharmaceutical Engineering, Biomedical Sciences, or related fields;
• Solid understanding of ISO 13485, NPRA's QUEST3+ online platform and regulatory requirements for medical device manufacturing;
• Licensed Pharmacist qualification is a strong advantage;
• Strong communication and teamwork skills;
• Required language(s): Bahasa Malaysia, English.
• Full time position(s) available
  
  

Job Benefits

• KWSP
• SOCSO
• Medical claim included
• Annual and medical leave shall be in accordance with the prevailing Labour Law