Quality Assurance Specialist – GMP

About the role

We are looking for a Quality Assurance Specialist to join our Tejo site and ensure that all products and processes meet cGMP standards and regulatory expectations. The role involves day‑to‑day oversight of quality activities, supporting continuous improvement of the Quality Management System and acting as a bridge between manufacturing, QC and regulatory teams.

Key responsibilities

• Maintain full compliance with cGMP, regulatory and internal quality standards for assigned products and projects.
• Support and improve the Quality Management System, keeping processes audit‑ready.
• Lead change controls, deviations, CAPAs, risk assessments, validation activities and new product introductions.
• Review, prepare and approve SOPs, protocols, batch records, specifications and quality agreements.
• Investigate deviations and non‑conformances, driving timely corrective and preventive actions.
• Coordinate internal, client and regulatory audits and ensure inspection readiness.
• Provide on‑site quality oversight on the production floor and collaborate with manufacturing, QC, regulatory affairs and suppliers.
• Participate in supplier qualification and drive continuous improvement initiatives.

Required profile

• University degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences or related field.
• 3–5 years of Quality Assurance experience in a GMP‑regulated pharmaceutical environment.
• Hands‑on experience with pharmaceutical manufacturing or quality operations under GMP.
• Strong knowledge of GMP regulations and quality systems (mandatory).
• Fluent written and spoken English.

Required skills

• GMP regulatory knowledge.
• Quality Management System (QMS) implementation.
• Deviation, CAPA and change‑control management.
• Audit coordination and inspection readiness.
• Validation and documentation review.
• Proficiency with Microsoft Office applications.