Pharmacist

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

Job summary

A leading pharmaceutical company in Kedah seeks a manufacturing oversight professional to ensure compliance with GMP and regulatory requirements. Responsibilities include monitoring the manufacturing processes, supporting audits and inspections, and ensuring product quality. Ideal candidates will have a Bachelor of Pharmacy and regulatory experience, with newly registered pharmacists encouraged to apply. This role offers a great opportunity for those looking to grow in the pharmaceutical industry.

Qualifications

• 3 - 4 years of experience is preferred.
• Newly registered pharmacist without manufacturing experience are encouraged to apply.

Responsibilities

• Ensure compliance with GMP, NPRA, and international guidelines.
• Maintain compliance with company SOPs and regulatory requirements.
• Oversee and monitor API manufacturing processes.
• Support regulatory inspections and audits.
• Promote safe handling of chemicals in manufacturing.

Skills

Regulatory requirements

Quality systems

Strong attention to detail

Education

Bachelor of Pharmacy from a recognized university

Registered with the Malaysian Pharmacy Board (MPB)

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 encouraged to apply
• Proficient in Regulatory requirements, Quality systems, Strong attention to detail