Section Lead
4 weeks ago
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.
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