We are a growing pharmaceutical company specialized in the manufacturing of sterile injectable products with terminal sterilization. We operate both as a manufacturer and as a Contract Manufacturing Organization (CMO), supporting international clients in the development and production of high-quality injectable medicines.
QC Supervisor – Chemical Laboratory
Key Responsibilities
- Supervise compliance with EU, FDA, and other applicable regulatory guidelines within the QC department
- Lead and manage analytical method transfers and suitability testing for new products
- Supervise a team of QC analysts, ensuring high cGMP and GLP standards are consistently maintained
- Ensure adherence to laboratory schedules and performance targets to meet regulatory and business requirements
- Coordinate laboratory activities supporting raw materials, in-process controls, finished products, cleaning validation, and stability testing
- Liaise effectively with Manufacturing, QA, Regulatory Affairs, and other departments to ensure timely completion of activities
- Drive continuous improvement initiatives within the QC laboratory and quality systems
- Support regulatory inspections and customer audits
- Develop and maintain training programs, SOPs, validation documentation, and compliance systems
- Provide day-to-day leadership, coaching, and performance management to QC staff (potentially across multiple shifts)
- Promote a strong culture of quality, accountability, and safety
Qualifications & Experience
- Degree in Chemistry, Pharmaceutical Chemistry, or a related scientific discipline
- Previous supervisory or technical specialist experience in a pharmaceutical QC laboratory
- Experience in sterile injectable manufacturing is highly desirable
- Strong knowledge of cGMP, GLP, and regulatory requirements (AIFA, FDA, ISO standards)
- Experience supporting customer and regulatory audits
- Proven experience in analytical method validation and transfer
- Experience leading analytical project teams
- Knowledge of SAP is considered an advantage
- Strong leadership, communication, and organizational skills
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