Qualified Person / Product Quality and Compliance Specialist
Cantanhede - Portugal
Tilray Brands is a leading global cannabis-lifestyle and consumer packaged goods company with operations in Canada, the United States, Europe, Australia, and Latin America that is changing people's lives for the better – one person at a time – by inspiring and empowering the worldwide community to live their very best life by providing them with products that meet
the needs of their mind, body, and soul and invoke a sense of wellbeing. Tilray's mission is to be the trusted partner for its patients and consumers by providing them with a cultivated experience and health and wellbeing through high-quality, differentiated brands and innovative products. A pioneer in cannabis research, cultivation, and distribution, Tilray's unprecedented production platform supports over 20 brands in over 20 countries, including comprehensive cannabis offerings, hemp-based foods, and alcoholic beverages.
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?
Responsible for monitoring the quality and compliance of the cannabis products, and assist to ensure that products are manufactured and tested in compliance with Portuguese regulations, GMP and GACP requirements, and other applicable regulations. Collaborates with Quality (Quality Assurance and Quality Control, Production (Cultivation and Manufacturing) and other departments, to ensure the quality and compliance of the products, and performs batch release 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 Responsabilities
Monitor production (cultivation and manufacturing) processes and support areas (warehouse, facilities, quality control, and others) and communicates results to respective area stakeholders;
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) ;
Responsible for batch release and for controlling batch release;
Assists to ensure compliance with INFARMED regulation, GACP guidelines and GMP requirements pertaining to production, processing, packaging, labeling and shipping;
Ensure compliance with regulations through internal auditing in cultivation, manufacturing, facilities and maintenance for inventory, GDP, GMP and process quality compliance;
Review of Manufacturing and Cultivation documentation (Master Batch Records);
Review of batch release documentation;
Participates in quality related activities (CAPA, deviations, change control);
Management of quality complaints;
Participates in investigation activities associated with problems or failures, to analyze root cause, to propose appropriate corrective action, and to document with deviation reporting tools;
Management of quality complaints;
Support elaboration and revision of Standard Operating Procedures (SOPs);
Supports creation of annual Product Quality Review;
Participation and follow-up of external audits and inspections;
Creates and communicates monthly KPI reports.
Qualifications and Education Requirements
Degree in Pharmaceutical Sciences with Specialist title on Pharmaceutical Industry
Must have 1 year experience in similar role
Strong knowledge of GMPs for pharmaceuticals
Detail oriented and self-directed in execution of tasks required, strong critical thinking skills
Proven ability to effectively use Microsoft Office Applications
Can communicate and comprehend English language is required
Must possess excellent communication skills for liaising and communicating with internal departments
Highly capable of multi-tasking, with minimal supervision
Able to interface directly with cross functional teams
Strong work ethic and positive team attitude
#J-18808-Ljbffr