Quality Assurance Lead: Complaints & CAPAs (GMP)

Chemo; Madrid; Presencial; EUR 42.000 - 64.000; Jornada completa

Descripción de la vacante

Chemo León is seeking a Quality Assurance professional to assure compliance of GMP, regulatory and internal standards across the site. You will manage complaints, CAPAs, returns and recalls, and support audits and the qualified person.

Requirements include a degree in Pharmacy, Chemistry or Sciences; 3 years in a similar role; fluent English and Spanish; knowledge of EU & US GMPs, SAP, TrackWise and quality systems; strong communication and organizational skills.

Formación

• Education: Degree in Pharmacy or Chemistry or Sciences.
• Languages: English (intermediate or high) and bilingual in Spanish.
• Experience: at least 3 years in a similar QA/QA position.
• Knowledge: EU & US GMPs, quality systems (Complaints, CAPAs), SAP, TrackWise.

Responsabilidades

• Develop SOPs to ensure compliance with internal and external regulations.
• Manage complaints with records, analysis, risk assessment and resolution.
• Coordinate investigations of complaints with other Departments; identify root causes.
• Manage CAPAs and closure of corrective actions.
• Support external audits and inspections per plan; assist qualified person.
• Support quality investigations and review internal SOPs.
• Manage GMP documentation and archive.

Conocimientos

Quality mindset

Communication skills

Proactivity

Organizational skills

Educación

Bachelor's degree in Pharmacy, Chemistry, or Sciences

Herramientas

SAP Management

TrackWise

Office suite

Descripción del empleo

Chemo León is seeking a Quality Assurance professional to assure compliance of GMP, regulatory and internal standards across the site. You will manage complaints, CAPAs, returns and recalls, and support audits and the qualified person.

Requirements include a degree in Pharmacy, Chemistry or Sciences; 3 years in a similar role; fluent English and Spanish; knowledge of EU & US GMPs, SAP, TrackWise and quality systems; strong communication and organizational skills.