Quality Control Assistant Manager

Range Pharma Sdn. Bhd.; Selangor; On-site; MYR 100,000 - 150,000; Full time

Job summary

A pharmaceutical company in Malaysia seeks a QC Assistant Manager to oversee the QC team, ensuring all activities align with GMP standards. The role involves managing laboratory testing schedules, approving materials, and participating in audits. Ideal candidates will have a degree in Chemistry or related fields and at least 5 years in manufacturing QC. Strong GMP/ISO knowledge and team management skills are essential for this position.

Qualifications

• Minimum 5 years of experience in a manufacturing QC environment.
• Strong experience in supervisory roles.
• Expertise in documentation control and GMP/ISO standards.

Responsibilities

• Oversee analytical testing schedules for compliance.
• Assist in managing the QC team and their performance.
• Approve/reject materials and authorize product releases.
• Manage laboratory equipment maintenance and calibration.
• Monitor laboratory consumables and supplier evaluations.
• Participate in audits and maintain the QC Risk Register.

Skills

GMP/ISO standards expertise

Analytical Testing

Team management

Documentation control

Education

Degree in Chemistry, Pharmacy, Science, or equivalent

Job description

The QC Assistant Manager reports to the QC Manager. You will assist in managing the QC team to ensure all manufacturing activities align with GMP standards and company objectives.

Responsibilities

• Analytical Testing Schedule: Overseeing testing schedule of physical, microbiological and chemical testing on laboratory samples to ensure 100% compliance and according to priority.
• Team Management: Assist with recruitment, training, and KPI/OKR monitoring of QC employee.
• Quality Authority: Assist with approving or rejecting starting materials, intermediates, and bulk products. Review batch records and authorize product releases.
• Equipment Management: Schedule and monitor routine calibration, qualifications, and maintenance of lab equipment.
• Lab Consumables: Overseeing laboratory consumables stock level monitoring and purchase.
• Supplier & Resource Control: Evaluate raw/packaging material suppliers and approve samples; assist in security/access management to the laboratories.
• Process Oversight: Oversee method validation, stability studies program, and environmental monitoring (HVAC/Water systems) to ensure GMP compliance.
• Audits & Risk: Participate in internal and external audits; perform risk assessments and maintain the QC Risk Register.
• Documentation: Prepare and review SOPs, test methods, and COAs; compile monthly operational performance reports and MRT meeting minutes.

Requirements

• Degree in Chemistry, Pharmacy, Science, or equivalent.
• At least 5 years of experience in a manufacturing QC environment, with prior experience in a supervisory role.
• Strong expertise in GMP/ISO standards and documentation control.
• Able to handle complex investigations and assist lead audit responses.