QA Manager

Our client is an innovative and
- growing pharmaceutical company based in Coimbra, dedicated to the development, production, and packaging of
- quality medical cannabis products. We are looking for a QA Manager to join the team.

• 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.

Profile

• 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.