Quality Assurance System Specialist

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

Valuing People. Science. Life - At Labatec Pharma, we are committed to deliver medicines that help to improve quality of life for patients around the world by meeting the needs of the hospital and retail sectors. We collaborate all together to deliver outcomes which add significant value to our clients’ projects and the community as a whole. Our people are at the center of Labatec Pharma.

Labatec is looking for talented individuals to join its growing team! Join us!

Your key responsibilities:

• 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.

We are looking for:

• 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

We will offer you

• A collaborative and friendly environment within a human-size company
• An established Company operating with agility
• Continuous professional training to develop your potential
• A rewarding compensation benefits package

About us

Labatec is a Swiss-based private pharmaceutical company, headquartered in Geneva, Switzerland. Our company has 60+ years experience in the production and supply of medicines to 11 countries comprising Switzerland, the Middle East and North Africa and expanding today in Europe. We aim to be a leading licensing partner in generic and specialty innovative medicines in our markets with an extensive portfolio of 70+ products in both the retail and hospital segments. We serve our communities by developing, manufacturing, and distributing high quality medicines covering major therapeutic areas such as musculo-skeletal, ophthalmology, anaesthetics, oncology, anti-infectives and women’s health.

For more information, please visit our website: