Cantanhede - Portugal
Tilray is a global leader in medical cannabis research and production dedicated to providing safe, consistent and reliable therapy to patients. We are the only GMP certified medical cannabis producer currently supplying products to thousands of patients, physicians, pharmacies, hospitals, governments and researchers in Australia, Canada, the European Union and the Americas. Our team of PhD scientists, botanists and master horticulturists are leaders in cannabis research and related agricultural sciences. We strive to improve scientific understanding of the potential applications of medical cannabis and have invested in developing continuing medical education programs for health care practitioners around the globe.
Looking to develop your career at the forefront of a rapidly expanding industry?
Ready to apply your talents to make a positive difference in the lives of patients around the globe?
Reporting to the Quality Manager, the Qualified Person (QP) is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in Portugal and with Good Manufacturing Practice (GMP)
Role and Responsibilities
- Oversee Tilray Quality Assurance as per INFARMED and Eudralex Vol 4 Part I GMP guidelines
- QP is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in Portugal and with Good Manufacturing Practice (GMP)
- QP is responsible for the batch release and for the controlling batch release
- The process of batch release comprises of:
- The checking of the manufacture and testing of the batch in accordance with defined release procedures.
- The certification of the finished product batch performed by a QP signifying that the batch is in compliance with GMP. This represents the quality release of the batch.
- The transfer to saleable stock, and/or export of the finished batch of product which should take into account the certification performed by the QP.
- The purpose of controlling batch release is notably to ensure that:
- The batch has been manufactured and checked in accordance with the requirements.
- The batch has been manufactured and checked in accordance with the principles and guidelines of GMP.
- Any other relevant legal requirements are taken into account.
- In the event that a quality defect as referred to in Chapter 8 of EudraLex, Volume 4, Part I, needs to be investigated or a batch recalled, to ensure that any QPs involved in the certification or confirmation and any relevant records are readily identifiable.
- Each batch of finished product must be certified by a QP within the EU before being released for sale or supply in the EU or for export.
- The QP who performs certification of the finished product batch may assume full responsibility for all stages of manufacture of the batch
- Conditions of storage and transport for the batch and the sample, if sent separately, should be taken into account by the QP before certification of a batch.
- QPs should be able to prove their continuous training regarding the product type, production processes, technical advances and changes to GMP.
- In the case of medicinal products coming from third countries, irrespective of whether the product has been manufactured in the European Union a Qualified Person must ensure that each production batch has undergone in a Member State a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements.
- The Qualified Person must certify in a register or equivalent document, as operations are carried out and before any release, that each production batch satisfies the provisions of Article 51.
Qualifications and Education Requirements
- Degree in Pharmaceutical Science with Industrial Specialization
- Strong knowledge of GMPs for pharmaceuticals/biotechnology.
- Ability to work independently and as part of a team
- Ability to comprehend regulatory requirements and technical documentation
- Excellent written and oral communication skills.
- Possess effective skills for developing, performing, evaluating, troubleshooting for operating systems
- Detailed knowledge of application of quality management systems.
- Competent knowledge of facility/utility/equipment/process/cleaning/computer systems qualification, new production introduction and commercial manufacture for pharmaceutical manufacturing facilities.
- Capable of troubleshooting/problem solving on issues associated with projects, process development etc.