In a few words

Position: R&D; QA Techinician.
Location: León.
Experience: Between 1-3 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), Branded (Exeltis), and Biotech (mAbxience), 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.

The challenge:

Collaborate with the Head of QA-R&D; of Chemo in order to assure the activities of R&D; Department are performed in compliance with the internal SOPs,



the GMP and EMEA and FDA legislation.

Specific Responsibilities:

• Collaborate with the Head of QA-R&D; in the implementation and maintenance of a Corporate Quality System in R&D; in compliance with GMP.
• Write and review corporate procedures which allow to standardize the R&D; Department activities and to assure their adaptation to the correspondent Good Manufacturing Practices.
• Review and approve documents generated by R&D; (i.e. Analytical validations, master batch records, procedures, and analytical methods).
• Review and approve executed batch records and analytical results of R&D; before their release.
• Issue and review R&D; analytical specifications.
• Perform internal and external audits.
• Collaborate with the Head of QA-R&D; in the preparation and attendance of clients audits and Health Authorities inspections.
• Issue and organize the documentation sent from QA to RA for new submission of MA

📌 R&D QA Technician (Castilla y León)
🏢 Chemo
📍 Castilla y León