In a few words

Position: Quality Assurance Specialist (Systems - PQRs & CCs)

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?

General Responsibility

Assure compliance of GMP, regulatory and internal standards according to quality policies and applicable requirements within the organization. Actively participate in the CAPAs management, support on PQRs, Change Controls, cleaning and process validations, 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.
- Review and approved internal SOPs
- Management of GMP documentations and related archive.
- Register, follow up and closing of CAPAs opened in the site.
- Support external audits and inspections according to the Annual Plan to assess the quality of the GMP system.
- Management of GMP documentations and related archive.
- Support to the qualified person.
- Elaborate and follow-up self-inspections program and conduct self-inspections.




- Support to Customers and Authorities request for quality and technical issues.
- Elaborate and follow-up training annual program.
- Support external audits and inspections according to the Annual Plan to assess the quality of the GMP system.
- Collaborate with supplier’s qualification management.
- PQR preparation according to timelines included in the annual plan, internal procedures and TA in force.
- Collaborate with Change Control management
- Support to quality activities according to the appropriate training.
- Validation activities related to manufacturing and cleaning processes
- Review and approval of the monitoring of pressures and temperature, done by the Engineering Dpto, of the different areas of the site.
- Support the qualification of equipments and systems for complying with GMPs.

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 (CAPAs, PQRs, audits support, validations, change controls, etc.) in pharmaceutical companies.

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!

📌 Quality Assurance Specialist (Systems - PQRs & CCs) (León)
🏢 Chemo
📍 León