Quality Assurance Manager

Há 5 dias

Lisboa, Portugal Hays Tempo integral

Your new company
Join a GMP-certified pharmaceutical company operating in the manufacture and distribution of medicinal cannabis products (GACP, GMP, GDP), as Quality Assurance Manager, based on-site in Torres Vedras and reporting to the Head of Quality.
Your new role
This professional will manage the day-to-day Quality Assurance activities and lead the Quality Assurance team, with responsibility for growing and developing it, while acting as Deputy QP and supporting batch certification. The role includes maintaining and improving the Quality Management System; overseeing deviations, CAPAs, change controls, complaints and risk assessments; reviewing batch records and leading batch disposition; overseeing qualification and validation of equipment, facilities, utilities and computerised systems; managing OOS/OOT investigations and PQRs; ensuring data integrity (ALCOA+) and GMP documentation standards; leading audit and inspection readiness; managing supplier and client qualification and Technical/Quality Agreements; managing Quality Assurance KPIs and regulatory reporting for controlled substances; supporting regulatory activities such as import/export permits; and overseeing artwork and labelling compliance under GMP.
What you'll need to succeed
We are looking for a professional with a degree in Pharmaceutical Sciences (mandatory) with at least 5 years of Quality Assurance experience in the pharmaceutical industry, in a GMP manufacturing environment. Proven experience leading a QA team is desirable, as well as strong experience in GMP quality systems (deviations, CAPAs, change controls, complaints, supplier qualification and audits), batch record review and batch disposition/release, and qualification and validation. Candidates from the cannabis sector must have solid prior experience in traditional pharmaceutical manufacturing. Fluency in Portuguese and English is mandatory. Experience with controlled substances and the Specialist title from the Ordem dos Farmacêuticos (or in progress) will be highly valued.
What you'll get in return
This is an excellent opportunity to take on a key quality leadership role in a growing pharmaceutical company.
What you need to know
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV. If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.