Stability QC Supervisor | GMP/GLP & Methods

Chemo; León; Presencial; EUR 45.000 - 65.000; Jornada completa

Descripción de la vacante

Laboratorios Leon Farma / Farmalan is seeking a Stability Analyst to plan, review, and record stability studies, supervise the team, and ensure adherence to GMP/GLP guidelines. You will create and review SOPs, coordinate with QA and Regulatory Affairs, and use SAP for materials and reagents.

Responsibilities include approving analytical data, developing stability protocols, and investigating deviations or OOS.

Formación

• Education: University degree in Chemistry or similar.
• Languages: High level of Spanish and English is necessary.
• Experience: Minimum 3-4 years’ experience in the functions mentioned above.
• GMP/GLP knowledge required.
• Travel: Open to travel.
• Personal skills: good analytical skills, accuracy and reliable.

Responsabilidades

• Organize, supervise and control the work of the team responsible for the analysis and sampling of stability samples in the required timeframes.
• Review and approve stability documentation (analytical data).
• Creation and review of analytical methods and SOP and control that these procedures are properly implemented and followed by staff.
• Create stability protocol and reports.
• Ask for stability samples to start the required stability studies.
• Assure that all activities of the Laboratory follow approved method, SOP, quality guidelines, etc.
• Investigate the cause of deviations and OOS and propose corrective actions under QA Technicians coordination.
• Develop no routine activities carried out in the laboratory (including actions arising from deficiencies found in audits, CAPAs, deviations) so they can be finished within the required timeframe.
• Make order requests in SAP system for reagents, standards and all the materials and services necessary.
• Provide technical assistance to analysts.
• Support Quality Assurance during customer and Authorities inspections of Quality Control Activities.
• Support Regulatory Affairs in the client or Authorities requests.
• Provide training of personnel following Quality Control training modules and annual training plan.
• Coordinate analytical methods implementation in Stability Area for new products stability studies.
• Review of stability chambers temperature and humidity taking actions if OOS of the parameters is detected.
• Train the new incorporations in the specific activities and functions of the position in which you are an expert.

Conocimientos

Spanish

English

Analytical skills

Accuracy

Reliability

Educación

University degree in Chemistry or similar

Descripción del empleo

Laboratorios Leon Farma / Farmalan is seeking a Stability Analyst to plan, review, and record stability studies, supervise the team, and ensure adherence to GMP/GLP guidelines. You will create and review SOPs, coordinate with QA and Regulatory Affairs, and use SAP for materials and reagents.

Responsibilities include approving analytical data, developing stability protocols, and investigating deviations or OOS.