PHARMACIST

SM Pharmaceuticals; Alor Merah; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading pharmaceutical company in Malaysia is seeking a qualified individual to ensure compliance with GMP and regulatory standards in manufacturing activities. Responsibilities include overseeing API manufacturing processes, supporting regulatory inspections, and monitoring product quality. Candidates must hold a Bachelor of Pharmacy, be registered with the Malaysian Pharmacy Board, and possess 3-4 years of relevant experience. Newly registered pharmacists are encouraged to apply for this role.

Qualifications

• Bachelor of Pharmacy from a recognized university.
• Registered with the Malaysian Pharmacy Board (MPB).
• 3 - 4 years of experience in a relevant field.
• Newly registered pharmacists are encouraged to apply.

Responsibilities

• Ensure all manufacturing and quality activities comply with GMP, NPRA, and relevant international guidelines.
• Oversee and monitor API manufacturing processes to ensure consistency, safety, and product quality.
• Support regulatory inspections, audits, and authority queries.
• Participate in continuous improvement projects to enhance efficiency, quality, and compliance.

Skills

Regulatory requirements

Quality systems

Attention to detail

Education

Bachelor of Pharmacy

Registered with the Malaysian Pharmacy Board

Job description

Responsibilities

• Ensure all manufacturing and quality activities comply with GMP, NPRA, and relevant international guidelines.
• Maintain compliance with company SOPs, policies, and regulatory requirements.
• Support regulatory inspections, audits, and authority queries.
• Oversee and monitor API manufacturing processes to ensure consistency, safety, and product quality.
• Ensure production activities are carried out according to approved Batch Manufacturing Records (BMRs).
• Review and verify production documentation for accuracy and completeness.
• Assist in process validation, cleaning validation, and scale-up activities.
• Ensure proper segregation, labeling, and storage of raw materials, intermediates, and finished APIs.
• Ensure data integrity practices are followed in all laboratory and production records.
• Support preparation and maintenance of regulatory dossiers (e.g. DMF, ASMF, technical files).
• Provide technical input for NPRA submissions, variations, and renewals.
• Ensure APIs meet regulatory specifications and customer requirements.
• Ensure proper receipt, testing, approval, and release of raw materials and packaging materials.
• Monitor controlled substances and critical materials in accordance with regulations.
• Ensure appropriate storage conditions and inventory traceability.
• Ensure compliance with safety, health, and environmental (SHE) requirements within manufacturing areas.
• Promote safe handling of chemicals, solvents, and hazardous materials.
• Participate in risk assessments and safety improvement initiatives.
• Provide GMP and technical training to production and quality staff.
• Participate in continuous improvement projects to enhance efficiency, quality, and compliance.
• Stay updated on regulatory changes, pharmacopeial updates, and industry best practices.

Qualifications

• Bachelor of Pharmacy from a recognized university.
• Registered with the Malaysian Pharmacy Board (MPB).
• 3 - 4 years of experience.
• Newly registered pharmacist, without experience in the manufacturing set-up are encourage to apply.
• Proficient in Regulatory requirements, Quality systems, Strong attention to detail.