About the job
We are seeking a highly skilled and experienced QC Manager to lead and manage our quality control laboratory in accordance with GMP standards. In this role, you will be responsible for overseeing laboratory operations, ensuring resource allocation, equipment management, and staff coordination to meet production demands. You will also ensure that all laboratory practices and documentation comply with pharmacopeia regulations. If you have a strong background in pharmaceutical quality control and a passion for ensuring product quality, we encourage you to apply.
Responsibilities
- Manage and oversee the QC laboratory operations to ensure compliance with cGMP standards, optimizing resources, equipment, personnel, and scheduling to meet production requirements.
- Review and approve analytical methods, specifications, sampling instructions, and testing procedures for chemical testing, ensuring compliance with pharmacopeia standards.
- Review and approve analytical methods, specifications, testing procedures, and environmental monitoring plans for microbiological testing, ensuring adherence to pharmacopeia regulations.
- Review and manage stability studies and stability programs for products.
- Review the release testing reports for raw materials and finished products, including stability testing reports.
- Lead and execute laboratory change controls and investigations for Out-of-Specification (OOS) results.
- Prepare for and respond to internal and external audits, ensuring laboratory and QC processes meet all regulatory standards, and track corrective actions following audits.
- Perform other duties as assigned by management.
Qualification
- Bachelor's degree or higher in Pharmaceutical Sciences, Chemistry, Microbiology, or a related field.
- At least 5 years of experience in a quality control role in the pharmaceutical industry, with at least 2 years in a managerial position.
- In-depth knowledge of GMP regulations and quality control processes.
- Experience with stability studies, analytical method validation, and laboratory investigations.
- Strong leadership skills with the ability to manage cross-functional teams.
- Excellent problem-solving abilities and attention to detail.
- Fluent in English.
- Strong communication and interpersonal skills, with the ability to work effectively with various departments and external partners.
Our company
PharmaEssentia Corp, is a Taiwan-based, full-spectrum biopharmaceutical company specializing in the innovation, clinical development, manufacturing, and global marketing of new drugs. Leveraging its deep expertise and core R&D capabilities, PharmaEssentia is committed to providing advanced treatment options in hematology and oncology, with self-developed product currently on the market and a continually expanding product portfolio.
More detail : Company informationR&D pipeline
