CMO QA SPECIALIST

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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:

• Bachelors degree in life sciences or Engineering desirable Pharmacy Chemistry or Biology.

• Desirable Education: Masters 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.