Quality Control Supervisor 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 Control Manager, the Quality Control Supervisor is accountable for performing analytical chemistry quality control testing to ensure the highest quality, potency and purity of Tilray products.
The Quality Control Supervisor is responsible for managing and supervising a group of Quality Control Technicians and analysts.
The incumbent is responsible for maintaining Quality Control operations inspection ready at all times in compliance with EU GMP.
Role and Responsibilities
Develop specifications for new SKUs
Manage analytical transfer and method validation for new SKUs
Qualify new equipment and maintain the qualification status of existing equipment
Oversee analytical laboratory operations including direct supervision of QC laboratory technicians
Review and approve all analytical data to support product testing and release.
Document test results, maintain batch records
Perform lab investigations, OOS / OOT investigations, and stability data monitoring in conjunction with QA
Perform routine calibration and maintenance on laboratory instruments
Assist in development and maintenance of validated quality control methods
Ensure compliance to internal standards and external regulatory requirements
Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site Standard Operating Procedures
Identify opportunities for improvement of analytical methods
Develop, author, implement and revise all Quality Control SOPs
Keep up to date with technical and regulatory advances in analytical sciences and relevant pharmacopeia
Develop and review analytical methods, validation protocols, reports, and method transfer protocols
Is the single point of contact for pharmacopeial updates and initiation of global changes
All other relevant duties as assigned.
Qualifications and Education Requirements
Must have a minimum of a B.Sc. (Chemistry, Biochemistry or Biotechnology), a M.Sc. is desirable
5 years of supervisory experience
A minimum of 3 years’ experience with HPLC, GC-MS, and other analytical instrumentation is a requirement
Experience with method validation, GLP compliance and creation of SOP’s
Excellent organization skills with proven ability to prioritize work for efficient operations
Experience with health authority inspection e.g. EMA, Infarmed, etc
Experience with CMC documentation and submission is a plus Substantial attention to detail is required
Proven ability to effectively use Microsoft Office