In a few words

Position: QA Technical Department

Location: León

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?

Integral Responsibility

Suppliers compliance and Management of quality technical agreements in accordance to internal procedures, GMPs rules, Authorities and customers requirements. EU & US GMP compliance. Assure compliance of GMP, regulatory and internal standards according to quality policies and applicable requirements within the organization.

Specific Responsibilities

- Review, negotiate and manage Quality Technical Agreements with customers, suppliers & third parties and services.
- Supplier’s qualification management: risk analysis performance, register update, annual audit plan preparation and follow up, evaluation of the documental compliance,



approval and certification status follow up, supplier status update on SAP system.
- Receipt, filling and delivery to customers of quality questionnaires to be filled by QA.
- ICH Q3D and nitrosamine reports review and management
- Elaborate and follow-up self-inspections program and conduct self-inspections.
- Support and external audits and inspections according to assess the quality of the GMP system.
- 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.
- Management of GMP documentations and related archive.
- Support and collaboration with the different activities related to the Qualified Person
- Review and management of quality related registration documents.

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.

Competencies/Career level

- Innovation, customer oriented, communication, team work, adaptability/flexibility, productivity, self-development, sense of urgency, initiative.
- Attention to detail, analytical mindset, compliance mindset, documentation rigor and organizational skills are especially valuable for this position.

Our benefits! ? ? Permanent contract

? 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? ?

Follow us on LinkedIn and Instagram so you don’t miss out on future career opportunities! #Leonfarma #Challenger #InsudPharma #InsudTalent 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!

📌 QA Technical Department (León)
🏢 Chemo
📍 León