- Lead daily activities in the QC laboratory to ensure efficient operations and high-quality results.
- Manage lab processes and workflows, implementing continuous improvements to enhance productivity and compliance.
- Coordinate analytical method transfers and validations for biotechnological products, focusing on peptides and recombinant proteins.
- Provide technical guidance and oversight to QC teams, ensuring accurate test method execution and adherence to GMP standards.
- Collaborate with R&D, QA, and Manufacturing to drive process alignment and support cross-functional projects.
- Develop and review SOPs, protocols, CAPAs, deviations, and method transfer documentation to meet regulatory expectations.
- Analyze root causes and support investigations using TrackWise.
- Optimize resource allocation, manage laboratory scheduling, and mentor junior staff to foster their growth and development.
- Select, train, and mentor a future QC Supervisor from the client's internal team to ensure seamless succession planning.
- 5–6 years of experience in Quality Control or Analytical Development within the pharmaceutical or biotech industry.
- Minimum 2 years of experience in a supervisory or team leadership role (e.g., QC Manager, QC Supervisor, Assistant QC Manager).
- Hands-on experience with techniques such as HPLC / UPLC, GC, LC-MS, UV-VIS, IR spectroscopy, KF titration, SDS-PAGE, etc.
- Strong knowledge of method validation and transfer, especially under GMP and ICH guidelines.
- Proficiency in lab software such as Empower 3, LIMS, TrackWise, and scientific instruments.
- Skilled in team planning, performance monitoring, and lab process optimization.
- Familiarity with Change Control, CAPA, deviation management, and data integrity best practices.
- Excellent organizational, documentation, and communication skills.
- Experience in project tracking, reporting, and technical problem solving.
- Leadership and team management
- Quality control and analytical development
- Lab process optimization
- Method validation and transfer
- GMP and ICH compliance
- LIMS and laboratory software
- Scientific instrumentation and techniques
- Project tracking and reporting
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Quality Control Manager - Rimini - PQE Group

Descrizione
Quality Control Manager
PQE Group, a world leader in the Pharmaceutical and Medical Device industries, seeks a highly experienced Quality Control Manager to join a project for one of our most important clients based in Anagni.
Main Responsibilities:
About You:
Key Skills:
Location:
Anagni (Italy) - 100% onsite. Available to travel within Italy and Europe.
Next Steps:
Initial HR interview -> Technical interview with Hiring Manager -> Proposal discussions or further steps.
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