drjobs Quality Assurance Operations Officer

Quality Assurance Operations Officer

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1 Vacancy
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Job Location drjobs

Sintra - Portugal

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

By clicking the Apply button I understand that my employment application process with Labatec Pharma will commence and that the information I provide in my application will be processed in line with Labatec Pharmas Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.



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 thehospital and retail sectors. Wecollaborate all together to deliver outcomes which add significant valueto 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 Operations Officer to join our QA this role you will be responsible for the compliance of the processes in place at the Factory Plant on the day-to-day activities.

Your key responsibilities

  • CAPA Management: Define action plans assess impact monitor implementation and perform effectiveness checks to ensure timely and proper closure.
  • Change Control Management: Evaluate change requests oversee implementation and verify closure and effectiveness of actions.
  • Product Quality Review (PQR): Prepare internal reports and apply statistical process control tools to continuously monitor process trends.
  • Risk Assessments: Prepare risk assessment reports for elemental impurities and nitrosamines for products manufactured on site.
  • Audits & Inspections: Support customer audits and health authority inspections. Monitor and follow up on CAPA implementation.
  • Self-Inspections: Conduct regular self-inspections in GxP areas and monitor follow-up actions.
  • Operational QA Support: Review executed weighing production and packaging instructions to support batch release.
  • Conduct sampling of equipment product-contact surfaces for cleaning validation/verification.
  • Training & Continuous Improvement: Deliver cGxP and internal standards training foster a strong quality and integrity culture and act as a catalyst for continuous improvement initiatives.
  • Digital Transformation: Support the implementation of electronic software for managing GxP initial and continuous training.

We are looking for

  • University Degree in pharmacy biology chemistry engineering or similar
  • 3 to 5 years experience in a similar role in the Oral Dosage forms pharmaceutical industry
  • Knowledge of GxP standards
  • Goof Knowledge of English both in oral and written conversation. French is a plus.
  • Mastery of common computer tools Ms- Office
  • Mastery of statistical process control tools
  • Good communication organizational skills proactive and looks for active (on the field) role.
  • Capacity to work independently and effectively with multidisciplinary teams.
  • Hands -on experience
  • High ethical standards pragmatic detailed collaborative and team player
  • Results driven positive attitude able to deal with multiple tasks simultaneously

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 womens health.

For more information please visit our website: Experience:

Manager

Employment Type

Full-Time

About Company

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