Portocanna is an EU-GMP Pharmaceutical Industry, strategically located in Portugal/Santarém, and our vision is to become the European reference in the phytomedicine sector as a reliable EU-GMP supplier of high-quality Medical cannabis-based products.Our culture thrives on a growth mindset, a commitment to excellence, and motivating individuals to give their best each day.We are actively seeking a highly skilled person for the role of Qualified Person, with proven experience in QA pharmaceutical industry, to bolster our in-house QP.As a QP, you will be responsible for ensuring that all products meet stringent quality benchmarks and regulatory requirements, leading to their certification for market release. Additionally, in your role as a QA Senior Specialist, you must demonstrate a proven track record of regulatory compliance, optimizing quality management systems, and upholding Good Manufacturing Practices (GMP) through meticulous batch documentation review, SOP verification, and process validation.Main Responsibilities:Ensure the effectiveness of the documentation control system implemented as well as guarantee the conservation, archiving and protection of the organization documents;Participate in the preparation/review of the quality management system documentation, and co-responsible in terms of compliance: Manufacturing Operations; Reconciliation; Deviations, Non-Conformances, Change Control, Complaints, Returns and other Quality Processes; Audits & Inspections, Health Authorities; Activity Reports and Quality Related topics.Responsible for pharmaceutical batch release as a Qualified Person under EU GMP guidelines.Certify that activities related to the manufacture and quality control laboratories of the manufactured batches were carried out following the legal requirements applicable to the organization's activities;Co-Responsible for delivery of quality assurance activities to ensure commercial products are manufactured in accordance with cGMP, corporate and regulatory requirements.Active member of cross-functional operational teams providing independent Quality support, guidance and expertise to ensure the highest Quality and Compliance standards are adhered to;Tutorship in the implementation of critical Projects to Portocanna.Co-Responsible in terms compliance requirements to enable: Manufacturing Operations; Reconciliation; Deviations, Non-Conformances, Change Control, Complaints, Returns and other Quality Processes; Audits & Inspections, Health Authorities; Activity Reports and Quality Related topics.Qualifications, Skills and Experiences:QP Certification – Ordem dos Farmaceuticos (Previous QP experience not required)Progressive experience in quality management roles within the pharmaceutical industry, with a mix of QC and QA practices.In-depth knowledge of pharmaceutical quality systems, cGMP regulations and regulatory requirements;Spoken and written English;Strong communication skills, with the ability to influence and inspire cross-functional teams.Ability to work effectively in a team and adapt to a dynamic environment.Excellent analytical skillsStrong business partnership skillsStrong ethical standards and a track record of following professional codes of conduct in handling information and maintaining confidentiality.If you would like to discuss this vacancy further or to discuss your career options in confidence, please send your profile to me at ****** our team!Come help us create an ecosystem that is driven by an innovatively efficient supply chain.
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