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Our client is an innovative and fast-growing pharmaceutical company based in Coimbra, dedicated to the development, production, and packaging of high-quality medical cannabis products. We are looking for a QA Manager to join the team.
Job Responsibility:
Manage the Quality Assurance Team
Manager to oversee company quality assurance policies
Maintain a Pharmaceutical Quality System according to GMP (Good Manufacturing Practices)
Develop, review, approve and maintain SOPs (Standard Operating Procedures) and quality assurance procedures
Assist with training staff on various practices and on standard operating procedures (SOPs) for new or updated processes
Work closely with other teams to implement changes to increase efficiency and to identify and establish corrective actions while still maintaining high levels of quality
Supervise the lifecycle of the products in place to ensure each step is completed correctly done and confirm that cannabis products are up to standards
Assist Qualified Person (QP) with Recalls and Complaints investigation and ensure they are performed according to quality and regulatory requirements
Develops quality assurance plans by conducting hazard analyses, identifying critical control points and preventative measures, establishes critical limits, monitoring procedures, corrective actions, and verification procedures
Manage site quality inspection activities, schedule and participate in compliance audits and where applicable, supplier quality assessments
Manage and support the validation and qualification studies
Manage the Change Controls and the Deviations raised in Quality System
Perform any other duties that may arise from time to time as a team, and as requested by the QP
Requirements:
Bachelor or Master's Degree in Pharmaceutical Sciences, Chemistry or related
Minimum of 3 years of experience in a regulated organization for the production of medicines
Experience/knowledge demonstrated in ISO, GLP, GMP, QMS or similar
Knowledge of written and spoken English
Ability to work in a result oriented, challenging environment
Ability to react to urgent situations and leadership capacity
Excellent interpersonal and communication skills, including speaking and writing
Computer knowledge from the MS Office user perspective
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