Microbiology Supervisor

**Microbiology Supervisor**

**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?**

Reporting to the Quality Control Manager, the Microbiology Supervisor will be responsible for the coordination of microbiology lab work at Tilray site to ensure the successful implementation of Tilray Microbiology Lab in order to achieve regulatory compliance and business goals. The Microbiology Supervisor will work closely with production, quality assurance and engineering to ensure that micro quality standards are established, implemented and maintained through all operations. The Microbiology Supervisor will implement microbiology procedures, assisting in investigations, and coordinate/support routine analysis of starting materials, raw material, APIs, intermediate and finished product according to established specifications and procedures to ensure the highest quality, safety, efficacy and purity of Tilray products. The Microbiology Supervisor will improve quality inspection, monitoring and other in-house processes with the objective of constant improvement of quality processes.

**Role and Responsabilities**
- Develop, implement, validate and maintain microbiology lab work/methods to ensure product quality and/or regulatory compliance with GMP and EU pharmacopeia requirements;
- Coordinate purchase of equipments, consumables and reagents as required;
- Ensure the in-house implementation of environmental monitoring of production areas for the detection of viable particles;
- Ensure the in-house implementation of microbiological test for starting materials, raw material, APIs, intermediate and finished product according to GMP and EU pharmacopeia requirements;
- Ensure the in-house implementation of microbiology monitoring of clean utilities (compressed air, nitrogen, water,).
- Ensure in house testing support for cleaning validation, process validation and in-process control as required;
- Review and approve data related to micro testing of finished product and/or raw materials;
- Review and approve all microbiology related data for compliance to GMP guidelines and lead corrective action required;
- Elaboration and revision of QC SOPs, test methods, test records to ensure compliance with regulatory requirements;
- Risk Assessment Analysis;
- Elaboration and revision of protocols and reports;
- Prepare and review certificates of analysis;
- Perform GMP audits, monitoring and communicate non-compliances and collaborate with respective departments on corrective actions;
- Support management of the Change Control System, Validation System and Deviation Investigation Reports (DIR), including Root Cause Analysis (RCA), Corrective and Preventative Action (CAPA). Ensure all reports are completed in timely manner;
- Ensure of compendial method updates implemented and evaluated as appropriate for products;
- Lead laboratory investigations (OOS/OOT/OOE);
- Ensure adequate micro trending’s as required;
- Ensure adequate training to all team members;
- Monitor the performance of employees within area;
- Ensure adherence to all policies and compliance with GMP documentation, Good Laboratory Practices in all laboratory operations;
- Participates in the preparation of regulatory submissions and preparation of CTD/DMF/QOS/SmPC where required;
- Ensure that scientific data supporting submissions are in compliance with the international regulations and all relevant guidelines and policies;
- Maintain a safe, clean and legally compliant workplace;
- Identify, investigate, correct and document potential quality and compliance issues;
- Establish methods to meet work schedules and co-ordinate work activities, with other departments;
- Resolve work problems and recommend measures to improve productivity and product quality;
- Motivate members through the setting of clear expectations;
- Coordinate with other supervisors, leads, and managers to obtain maximum use of resources;
- Plan for manpower and equipment needs according to schedule;
- Ensure compliance with company standards for cost control, w