Section Lead - RM/PM Quality Control

Job Summary:

• The position is responsible to lead the Raw Material section and Quality Control at Sun Pharma, Malaysia, and is accountable for assuring the supply of high-quality and GMP compliant drug products to Sun Pharma customers and business markets.
• Provide training to staff on SOPs, cGLP, and cGMP standards.
• System owner for LIMS Malaysia.

Job Description:

• Manage QC operations for receipt, testing, and approval/rejection of all incoming RM/PM (Raw Material and Packing Materials).
• Daily planning of RM/PM sampling and testing.
• Ensure timely testing and release of all test samples (RM/PM) as per approved specifications, STP, and customer requirements.
• Review & approve RM/PM data summary reports and certificates of analysis for accuracy and completeness.
• Documentation compliance as per SOP on Good Documentation Practices and cGMP Guidance for documents taken in Laboratory Control and Management.
• Ensure the lab testing is approved and contracts for analysis are available before utilizing services.
• Involve in OOS/OOT/Laboratory investigations and conduct detailed investigations and propose and implement appropriate CAPA.
• Review analytical documentation and approval of certificates of analysis.
• Coordinate the technology transfer of products during new product launches.
• Pharmacopoeia review of specifications and management of the document control system at the plant.
• Review and approve specifications, sampling instructions, test methods, and other QC procedures.
• Monitor project and other expenses of the laboratory in the running year and monitor project and capital investments.
• Support Regulatory Operations for submissions, including timely submission of RM/PM related support.
• Provide support/response to internal/external audit observations for laboratory computerized systems and ensure compliance.
• Ensure the quality policies, standards, and procedures for computerized systems are implemented and adhered to at the site.
• Ensure all GxP computerized systems are validated in compliance with the quality policies, standards, and procedures and are maintained in a validated state throughout the lifecycle.
• Review/support to draft responses to internal/external audit observations for computerized systems and ensure compliance.

Job Requirement:

• Minimum 7 years of experience in Pharmaceutical Quality Control related field.
• Possess a bachelor's degree or master's in science.