QA-Operations Senior Specialist

Competitive annual gross salary + variable linked to objectives.

Social benefits package (private medical insurance, share plan, company canteen, continuous training, among others).

Flexible start time (7:30h to 9:30h); intensive working day on Fridays

A dynamic, collaborative, and innovation-focused work environment, with opportunities for professional development.

At PharmaMar, we are looking for a QA Operations Senior Specialist to join the Quality Assurance and Technical Management (QA-QP) area within the Quality Unit.

PharmaMar is committed to innovation in oncology and biotechnology, developing advanced therapies in a highly regulated environment, where quality, regulatory compliance, and continuous improvement are key elements to guarantee the safety, efficacy, and availability of our products.

• Guarantee compliance with GMP/GDP and internal procedures during production operations related to the manufacture, control, and distribution of APIs, intermediate products, and final products.
• Review and approve procedures, documentation, and records associated with the manufacturing activities of APIs, intermediates, and final products.
• Release batches of APIs and intermediates manufactured at PharmaMar after reviewing the corresponding documentation and verifying their conformity with established specifications, or proceed with their rejection when appropriate.
• Review and release packaging materials.
• Manage the qualification, evaluation, and periodic re-evaluation of suppliers.
• Prepare, review, and approve Quality area documentation, procedures, and reports related to manufacturing operations.
• Manage deviations, CAPAs, change controls, and other quality events associated with the manufacture of APIs, intermediates, and final products.
• Coordinate and participate in internal audits, external collaborator audits, and regulatory inspections.
• Manage GMP/GDP audits of external suppliers.
• Prepare and review annual product quality review reports.
• Participate in the evaluation, selection, and approval processes for new suppliers.
• Review and approve stability programs and protocols for APIs, intermediates, and final products.
• Ensure the availability of stability data that allows for the establishment and justification of re-evaluation or expiration dates, as well as storage conditions.
• Manage the GxP documentation archive.
• Collaborate in activities related to the market recall of defective or falsified product batches when necessary.
• Review the CMC documentation associated with the regulatory registration and maintenance of PharmaMar products.
• Promote continuous improvement initiatives aimed at strengthening and optimizing the Quality System.