Quality Assurance Operations Officer

About the role

Labatec Pharma is seeking a Quality Assurance Operations Officer to join its QA team in Sintra. Reporting to the Quality Assurance Manager, the officer will ensure day‑to‑day compliance of manufacturing processes with GMP, GDP and internal standards.

Key responsibilities

• Manage the Training Management System and deliver GMP, GDP and internal standards training.
• Prepare internal Product Quality Review reports and apply statistical process control tools for continuous monitoring.
• Revise master batch records and support batch release activities.
• Perform routine factory tasks such as sampling for cleaning verification, reviewing internal procedures, logbooks and environmental conditions of GMP/GDP areas.
• Draft, review and obtain approval for quality documentation, standard procedures and reports in line with Good Documentation Practices.
• Conduct internal GMP/GDP audits, follow‑up on CAPA plans and promote data integrity and continuous improvement.
• Support risk assessments, partner with operational departments to propose process improvements and ensure compliance.
• Assist the Responsible Person for Distribution in GDP activities and review deviations for compliance.

Required profile

• University degree in Pharmacy, Biology, Chemistry, Engineering or a related field.
• 3–5 years of experience in a similar QA role within the oral dosage forms pharmaceutical industry.
• Good knowledge of GxP standards and fluent English (both spoken and written); French is a plus.
• Proactive, organized and able to work independently in a multidisciplinary environment.

Required skills

• Knowledge of GxP standards.
• Proficiency with MS Office.
• Experience using statistical process control tools.