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QA Manager

2 semanas atrás

Coimbra, Coimbra, Portugal Randstad Portugal Tempo inteiro

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.

  • 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.