Position: QA Specialist - Complaints & CAPAsExperience: 2-5 yearsWant 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?General ResponsibilityAssure 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 ResponsibilitiesDevelop 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 classificationReview 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 skillsEducation: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 groupOngoing training and an innovative working environmentSubsidised canteen and other employee benefitsWhat 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!#J-18808-Ljbffr

📌 Qa Specialist - Complaints & Capas (León Site) (Madrid)
🏢 Chemo
📍 Madrid