cmo qa specialist
hace 1 semana
Actual Talent is the talent acquisition consultancy that offers Executive Search, RPO and Talent Solutions.
Our purpose is to drive the growth and fulfillment of individuals and organizations. We facilitate individuals in finding inspiring opportunities and help organizations discover professionals who will take them to the next level. We do this through talent acquisition and development solutions that focus on people, diversity and inclusion, innovation, and cutting-edge technology.
About the client:
We are seeking a CMO QA Specialist to join one of our clients in the pharmaceutical sector. The position is based in Barcelona and offers a hybrid work model.
Your mission:
This role as an CMO QA Specialist is responsible for maintaining and improving an effective and efficient quality assurance system that ensures the compliance with current regulations (including but not limited to: GMP, GDP and ICH Quality guidelines) to guarantee that medicinal products manufactured by external contract manufacturing organizations (CMOs) are consistently produced, tested and distributed in accordance with the quality standards appropriate to their intended use and as required by the Marketing Authorization, which ensures the quality, efficacy and security of the medicinal products for patients.
Your major accountabilities:
Become the expert regarding the quality along the lifecycle management of the assigned molecules and FDFs, which includes changes in manufacturing and testing, resolving quality incidents, addition of new sources of API and any change that could affect the manufacturing process related with external CMOs.
Write, review and approve technical documents: SOPs, master batch manufacturing records, analytical methods, material lists, specifications, stability studies, filed dossiers, Quality Agreements, environmental conditions, etc.
Write, review, approve and monitor CAPAs, deviations, OOS, complaints, change controls etc.
Write, execute or review qualifications (equipment, utilities, facilities, suppliers, providers, etc.) and validations (e.g. process, cleaning, transport, etc.).
Write, review and approve Product Quality Review reports.
Perform Compliance checks (internal procedures vs filed documentation).
Execute internal and external audits. Attend audits/inspections from Health Authorities and customers.
Prepare and execute GMP training.
Attend requests regarding quality related to marketed products.
Participate on the assigned projects.
Supervise the quality of the product and drive continuous improvement.
Support the assigned Product Lifecycle projects.
Supervise activities of the CMOs.
Supplier qualification management.
We would like to have:
Bachelor's degree in life sciences or Engineering, desirable Pharmacy, Chemistry or Biology.
Desirable Education: Master's degree in Pharmaceutical Industry.
Specific Knowledge: GMP, Quality Management System: deviations/investigations, complaints, audits, etc.
Good knowledge in SAP, Office and LIMS.
Minimum 2 years in a Quality Assurance Department, ideal 5 years.
Open mentality to new projects and changes.
Fluent in english and spanish.
Open to occasionally attend courses and conduct audits.
Advanced analytical thinking, stress management and quality orientation skills.
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