Quality Assurance System Specialist

Labatec Pharma SA; Viseu; Presencial; EUR 40 000 - 60 000; Tempo integral

Resumo da oferta

Labatec Pharma SA is seeking a Quality Assurance System Specialist to join its QA team. The role focuses on maintaining the Pharmaceutical Quality System (PQS) to ensure GMP compliance and drive continuous improvement across quality processes.

You will manage SOPs, document control, GMP training, internal audits, change controls, CAPA, risk assessments and KPI reporting, while overseeing electronic QMS platforms and data integrity in a fast-paced environment.

Qualificações

• Degree in Pharmacy, Pharmaceutical Sciences, Chemistry or related field.
• 3–5 years in Quality Assurance within pharma, GMP environment preferred.
• Strong knowledge of EU GMP and QA systems.
• Experience with QMS/PQS and electronic QA platforms.
• Experience in deviations, CAPA, change controls and risk assessments.
• Audits and inspections experience; document lifecycle management.
• Good English; French is a plus.

Responsabilidades

• Manage SOPs, policies, forms and quality documents lifecycle.
• Ensure periodic review, document control and training systems.
• Oversee GMP/quality training and staff readiness.
• Conduct internal audits and CAPA follow-ups.
• Assess quality/regulatory impact of changes; close actions.
• Oversee deviation handling, root-cause analysis and CAPA effectiveness.
• Utilize risk tools and integrate QRM into processes.
• Establish/monitor KPIs and report to management.
• Manage electronic QMS workflows, access and data integrity.

Conhecimentos

Quality mindset

Cross-functional collaboration

Analytical thinking

Problem-solving

Documentation control

Communication skills

Attention to detail

Training and coaching

Formação académica

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

Ferramentas

eQMS platforms

Microsoft Word

Microsoft 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!

We are currently looking for a Quality Assurance System Specialist to join our QA team.

The Quality Assurance System is mainly responsible for maintaining, overseeing, and continuously improving the Pharmaceutical Quality System (PQS) to ensure that the company operates in compliance with GMP, regulatory requirements, and internal procedures.

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.
• Act as a catalyst for continuous improvement and promote the importance of high Quality and Integrity standards;

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.