QA Specialist - Complaints & CAPAs (León site)

Chemo; León; On-site; EUR 40,000 - 60,000; Full time

Benefits offered by this job

Subsidised canteen

Employee benefits

Job summary

Chemo in León, Spain, is seeking a QA Specialist for Complaints & CAPAs to ensure GMP compliance across the global supply chain. The role focuses on handling complaints, CAPAs, returns, recalls, and site services compliance in line with internal procedures, GMPs, and customer requirements.

You will develop standard operating procedures, manage complaint investigations, identify root causes, drive corrective actions, support external audits, and assist the Qualified Person.

Qualifications

• 3+ years in QA in pharmaceutical sector
• Experience managing complaints and CAPAs
• Knowledge of EU & US GMPs
• English intermediate or higher, Spanish bilingual
• Experience with QA systems and documentation control

Responsibilities

• Assure compliance of GMP, regulatory and internal standards
• Manage complaints, CAPAs, returns, recalls and site services compliance
• Coordinate investigations with other departments and identify root causes
• Lead corrective and preventive actions (CAPAs)
• Support external audits and inspections
• Assist the qualified person and review internal SOPs

Skills

Quality Assurance

SAP

Trackwise

Office Suite

Communication

Education

Degree in Pharmacy or Chemistry or Sciences

Tools

SAP

Trackwise

Office Suite

Job description

Position: QA Specialist - Complaints & CAPAs

Experience: 2-5 years

Want to know more?

INSUD PHARMA operates across the entire pharmaceutical value chain, providing specialized knowledge and experience in scientific research, development, manufacturing, sales, and marketing of a wide range of active pharmaceutical ingredients (API), finished dosage forms (FDF), and branded pharmaceutical products, adding value to human and animal health.

The activities of INSUD PHARMA are organized into three synergistic business areas: Industrial (Chemo) and Branded (Exeltis), with over 9,000 professionals in more than 50 countries, 20 state-of-the-art facilities, 15 specialized R&D centers, 12 commercial offices, and more than 35 pharmaceutical subsidiaries, serving 1,150 customers in 96 countries worldwide. INSUD PHARMA believes in innovation and sustainable development.

Ready to be a #Challenger?

Global Responsibility

Assure compliance of GMP, regulatory and internal standards according to quality policies and applicable requirements within the organization. Complaints and CAPAs management, returns, recalls, and site services compliance in accordance to internal procedures, GMPs rules, Authorities and customers requirements, among other tasks of the area. Site services compliance in accordance to internal procedures, GMPs rules, Authorities and customers requirements. EU & US GMP compliance.

Specific Responsibilities

• Develop standard operating procedures (general quality and departmental) to ensure that the steps are collected in each case and comply with internal and external regulations applicable in each case.
• Manage of complaints according to internal procedures complaints. Complaints records, analyses, risk assessment and resolution of complaints. Complaints archive and classification
• Review and coordinate with other Departments the investigation of the complaints. Identification of root causes and responsibilities. Follow up of related corrective/preventive actions.
• Corrective and Preventive Actions (CAPAs) Management.
• Support external audits and inspections according to the Annual Plan to assess the quality of the GMP system.
• Support to the qualified person.
• Support on quality investigations. Review and approved internal SOPs.
• Management of GMP documentations and related archive.

Requirements and personal skills

• Education: Degree in Pharmacy or Chemistry or Sciences.
• Languages: Intermediate or high level of English required and bilingual in Spanish.
• Experience (years/area): A minimum of 3 years' experience in similar position.
• Specific Knowledge: Knowledge of EU & US GMPs, quality systems (Complaints, CAPAs) in pharmaceutical companies. Experience in Quality Assurance, SAP Management, Office system, Trackwise.
• Personal skills: Good communication skills, proactivity, good working under pressure, problems-solving, good organizational skills and persistent.

Career progression and development within a growing international group

Ongoing training and an innovative working environment

Subsidised canteen and other employee benefits

What will the recruitment process be like?

Initial contact by phone or email with our Talent Acquisition team. 1 or 2 face-to-face interviews at our premises in León. Regular updates on the progress of the process.

Do you think this role isn't for you?

COMMITMENT TO EQUAL OPPORTUNITIES AT LEONFARMA, we believe in and act to promote genuine equality of opportunity. We do not discriminate on the basis of gender, ethnicity, religion, sexual orientation, disability or any other characteristic. We value diversity and talent. We'd love to meet you!