Portugal Job Openings
Tilray
Qualified Person and Product Quality and Compliance Specialist
Cantanhede
October 9, 2024
Ready to apply your talents to make a positive difference in the lives of patients around the globe?
- 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.
- 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
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