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Quality control supervisor

Monte (Provincia di Varese)
Contratto a tempo indeterminato
Galenica Senese S.r.l. Industria Farmaceutica
Pubblicato il 13 marzo
Descrizione

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.

To strengthen our Quality Control Department, we are looking for an experienced and motivated 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

Fluent English (written and spoken)

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