QA Systems Strategist: GMP, QMS & Audits

Labatec Pharma Sa; Lisboa; Presencial; EUR 42 000 - 64 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Continuous professional training

Competitive compensation package

Resumo da oferta

Labatec Pharma Sa is seeking a Quality Assurance professional to lead SOP lifecycle management, ensure GMP training, and conduct internal audits across GxP areas. The role involves overseeing deviations, CAPA, change controls, and risk assessments within a growing pharmaceutical framework.

You will work with cross-functional teams to maintain QMS/eQMS systems, monitor KPIs, and drive continuous quality improvements. A relevant science degree and 3–5 years of QA experience are expected.

Qualificações

• Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Life Sciences, Engineering or a related scientific field.
• 3–5 years of experience in Quality Assurance within the pharmaceutical industry, preferably in a GMP manufacturing environment.
• Strong knowledge of EU GMP/GMP requirements and pharmaceutical quality systems.
• Experience with Quality Management Systems (QMS/PQS) and electronic quality management systems (eQMS).
• Practical experience managing or supporting deviations, CAPA, change controls and quality risk assessments.
• Experience with SOP and document management, including document lifecycle and periodic review.
• Experience supporting internal, supplier and regulatory audits/inspections.
• Good understanding of root cause analysis and investigation methodologies.
• Experience with quality metrics, trending and identification of recurring/systemic quality issues.
• Good understanding of GMP training systems and training compliance.
• Experience in continuous improvement and quality system enhancement.
• Ability to work effectively with cross-functional teams, including Production, QC, Engineering, Supply Chain and Regulatory Affairs.
• Strong analytical, organisational and problem-solving skills.
• Ability to challenge processes constructively and make risk-based quality decisions.
• Excellent written and verbal communication skills.
• Fluent English; Frensch is an advantage.
• Proficient in Microsoft Office, particularly Word and Excel; experience with electronic QMS platforms is an advantage.
• Detail-oriented
• Proactive and accountable
• Structured and organised
• Analytical and critical minded
• Pragmatic and solution-oriented
• Comfortable working in a fast-paced and changing environment

Responsabilidades

• Manage the lifecycle of SOPs, policies, forms and quality documents; ensure periodic review and document control
• Manage GMP/quality training systems and ensure personnel are appropriately trained before performing activities
• Conduct Internal Audits (Conduct regular self-inspections to the different GxP areas and periodically following-up CAPA plan)
• Ensure changes are appropriately assessed for quality/regulatory impact, approved, implemented and closed
• Oversee deviation processes, complete investigation quality, root-cause analysis and CAPA effectiveness
• Ensure appropriate use of risk assessment tools and integration of QRM into quality processes
• Establish and monitor quality KPIs, trends and periodic reporting to management
• Manage/oversee electronic QMS and related quality systems, including workflows, access, data integrity and system improvements

Conhecimentos

Quality Assurance

GMP/GxP

Audit

QMS/eQMS

CAPA

Document management

Data analysis

Cross-functional teamwork

MS Office

English proficiency

Formação académica

Bachelor’s or Master’s degree in Pharmacy or related scientific field

Ferramentas

QMS/eQMS software

Microsoft Word/Excel

Descrição da oferta de emprego

Labatec Pharma Sa is seeking a Quality Assurance professional to lead SOP lifecycle management, ensure GMP training, and conduct internal audits across GxP areas. The role involves overseeing deviations, CAPA, change controls, and risk assessments within a growing pharmaceutical framework.

You will work with cross-functional teams to maintain QMS/eQMS systems, monitor KPIs, and drive continuous quality improvements. A relevant science degree and 3–5 years of QA experience are expected.