Quality Assurance Operations Officer

About the role

Labatec Pharma is seeking a Quality Assurance Operations Officer to join its QA team in Sintra. The role focuses on ensuring day‑to‑day compliance of manufacturing processes with GMP and GDP standards and supporting continuous improvement across the factory.

Key responsibilities

• Manage the Training Management System and deliver GMP, GDP and internal standards training.
• Prepare Product Quality Review reports and apply statistical process control tools for trend monitoring.
• Review master batch records, support batch release, and perform routine factory tasks such as sampling for cleaning verification and environmental monitoring.
• Draft, review and obtain approval for quality documentation in line with Good Documentation Practices.
• Conduct internal GMP/GDP audits, follow up on CAPA plans and promote data integrity.
• Support risk assessment activities and act as a catalyst for continuous improvement.
• Partner with operational departments to provide QA support, 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 ability to communicate effectively in English; French is a plus.
• Strong organizational skills, proactive attitude and ability to work independently within a multidisciplinary team.

Required skills

• Good Manufacturing Practice (GMP) knowledge.
• Good Distribution Practice (GDP) knowledge.
• Statistical Process Control (SPC) tools.
• MS Office proficiency.
• Good Documentation Practices.