Senior Quality Assurance Specialist

Senior Quality Assurance Specialist
Sintra
Sintra, Lisboa, Portugal

Lisbon, Portugal

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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/Responsible Person in Switzerland. 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:

• Maintain Quality procedures, work instructions and forms up to date for processes under his/her responsibilities.
• Responsible for monitoring and maintaining an effective CAPA process.
• Change Control Process - Initiate and manage changes control requests. Maintain, improve, and monitor the Change Control Process.
• Handle product complaints and deviations in a timely manner.
• Review internal PQRs for products distributed by Labatec Pharma.
• Compile and review all the documentation necessary for the release to the market (Switzerland and MENA) by the Swiss Responsible Person.
• Participate to customers, suppliers and subcontractors' qualification and verification process (Switzerland, MENA. . . ).
• Write and maintain Quality Agreements with external partners (incl. contract manufacturers, service providers).
• Participate to Artwork review process improvement and check of artworks.
• Responsible for Transport risk assessment.
• Active involvement in projects, major changes and continuous improvement for Labatec Quality Management Systems as needed.
• Participates in the organization and preparation of Management Reviews. Develop and compile quality indicators related to quality systems (Key Performance Indicators).
• Participate in the preparation, execution and
  - up of internal and external Quality Management System audits and inspections by authorities.
• Participate in the validation of computerized systems as required.

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.
• Experience in working on complex problems where analysis of situations or data requires an
  - depth evaluation of various factors.
• Extensive knowledge of Gx
  P

• Fluent in English (verbal and written).
• Able to work in
  - country/functional teams and team player.
• Rigorous and methodical, analytical mindset and
  - solving skills.
• Demonstrate commitment to excellence.
• Curious and fast learner.

We will offer you

• A collaborative and friendly environment within a
  - 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

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
- skeletal, ophthalmology, anaesthetics, oncology,
- infectives and women's health.

For more information, please visit our website: