Section Head - Quality Control Raw Material/Packing Material (RM/PM)

Ranbaxy Malaysia; Kota Sarang Semut; On-site; MYR 80,000 - 120,000; Full time

Job summary

A leading pharmaceutical company in Malaysia is seeking a Section Head for Quality Control of Raw and Packing Materials. This role includes overseeing QC operations, ensuring compliance with documentation and regulatory standards, and managing testing schedules. Candidates must have experience in the pharmaceutical industry and a strong understanding of quality assurance practices.

Qualifications

• Candidates must have relevant pharmaceutical industry experience.
• Experience in managing QC operations with strong understanding of SOPs and cGMP guidelines.

Responsibilities

• Manage QC operations for testing and approval of RM/PM.
• Review and approve documents and specifications for compliance.
• Coordinate product technology transfers during launches.

Skills

Quality Assurance

Document Control

Laboratory Management

Regulatory Compliance

Education

Relevant qualifications in Pharmacy or Science

Job description

Section Head - Quality Control Raw Material/Packing Material (RM/PM)

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Manage QC operations for receipt, testing, and approval/rejection of all incoming RM/PM (Raw material and Packing materials).

Plan daily RM/PM sampling and testing schedules.

Ensure timely testing and release of all test samples (RM/PM) according to approved specifications, STP, and customer requirements.

Review and approve RM/PM data summary reports and Certificates of Analysis for accuracy and completeness.

Maintain documentation compliance as per SOP on Good Documentation Practices and cGMP guidelines for laboratory control and management.

Ensure lab tests are approved and analysis contracts are in place before utilizing services.

Participate in OOS/OOT/laboratory investigations, conduct detailed investigations, and implement appropriate CAPA.

Review analytical documentation and approve Certificates of Analysis.

Coordinate technology transfer for products during new product launches.

Review pharmacopoeia specifications and manage document control systems at the plant.

Review and approve specifications, sampling instructions, test methods, and other QC procedures.

Monitor laboratory project expenses, including operational costs and capital investments.

Support regulatory operations with timely submissions related to RM/PM.

Respond to internal and external audit observations concerning laboratory computerized systems and ensure compliance.

Implement and adhere to quality policies, standards, and procedures for computerized systems at the site.

Validate all GxP computerized systems and maintain their validated state throughout their lifecycle.

Support and draft responses to audit observations for computerized systems, ensuring compliance.

Note: Only candidates with relevant pharmaceutical industry experience will be considered for this position.