Senior Quality Assurance Specialist

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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 Senior Quality Assurance Specialist to join our Quality Assurance Team. The role is based in Sintra reporting to our Head of Quality. We are looking for a dynamic and motivated person, who can support our growth ambitions and add knowledge, competence, and team spirit.

Your key responsibilities:

To lead the end-to-end Quality oversight of Labatec’s supplier and service provider portfolio. You will ensure the integrity of associated supply chains through robust qualification, performance monitoring, and project management, maintaining strict compliance with GMP/GDP standards, regulatory requirements, and internal Labatec protocols.

• Change management: Ensure that all changes to GxP are effectively managed through the supplier and LBT change control processes in order to maintain GxP and regulatory compliance;
• Complaints management: Ensure suppliers conduct proper investigations of complaints and manage product complaints within LBT QMS;
• Product Quality Reviews: Confirm PQRs are completed by suppliers (whenever applicable), trends are identified and corrective/preventive actions are implemented.
• Supplier Performance Tracking: Monitor suppliers’ performance using KPIs and quality metrics, driving continuous improvement initiatives and supplier development initiatives as needed;
• Support Labatec global audit program by planning, preparing and conducting audits of external suppliers, including onsite and remote audits;
• Take ownership of transport risk assessments to safeguard product integrity throughout the distribution chain..
• Collaborate, whenever applicable, cross-functionally within the internal stakeholders to support product lifecycle activities and CMO management;
• Participation to quality relevant projects and other improvement projects, aligned with Quality Strategy;
• Maintain Quality procedures, work instructions and forms up to date for processes under his/her responsibilities.
• Write and maintain Quality Agreements with external partners (incl. contract manufacturers, service providers).
• Participate to Artwork review process improvement and check of artworks.
• Participate in the preparation, execution and follow-up of internal and external Quality Management System audits and inspections by authorities.

We are looking for

• University degree in Pharmacy, Biology, Chemistry, Engineering, or similar.
• 5-7 years of experience in quality assurance in the pharmaceutical industry.
• Extensive knowledge of GxP
• Auditing experience, incl. excellent working knowledge of international GxPs for the manufacture, control and distribution of commercial product and clinical trial materials;

• Fluent in English (verbal and written).
• Able to work in cross-country/functional teams and team player.
• Rigorous and methodical, analytical mindset and problem-solving skills.
• Demonstrate commitment to excellence.
• Curious and fast learner.
• Extensive knowledge of international authority regulations (e.g., PICs, ICH, and FDA) including applicable ISO norms. Additional knowledge of R+D requirements are of advantage;
• Knowledge of the principles of solid, semi-solid and liquids dosage manufacturing processes (tablets, capsules, gels, creams, ointments), experience with aseptic manufacture would be beneficial;
• Show deep understanding of end-to-end supply chains and proactively assesses the potential impact of quality issues on supply continuity and product availability;

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

If you are interested in this opportunity, please send your CV to hr.pt@labatec.com

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: http://www.labatecpharma.com/about-us/