We are looking for a proactive person to be part of the Quality Assurance department of the Clinical Trials Distribution (CTD) business unit. The CTD QA Associate will assist the QA Manager in the development, implementation and maintenance of the Quality Management System, in compliance with GMP, GDP and local regulations for pharmaceutical products.
- Acting as a QA documentation manager, ensuring the availability of documentation both in paper and in electronic form.
- Assist in the management of CAPA plans, collection of CAPAs information and identification and implementation of improvements in the quality system.
- Provide support in tracking, closing and archiving diversions, Complaints, audit observations, exchange controls and CAPAs.
- Conduct verification of incoming materials in compliance with Marken SOPs.
- Cooperate with clients in QA / GMP aspects.
- Conduct internal audits, carrying out the corresponding reports, evaluations and follow-up of associated corrective and preventive actions.
- Assist the Quality Manager during external supplier auditing processes, as part of the qualification process.
- Provide support during customer audits and regulatory inspections.
- Conduct GMP, GDP and QA SOPs, as required.
- Provide support during QA review of qualification protocols.
- Provide assistance during recall processes and provide support during the annual drill.
- In the absence of the QA Manager, coordinate and carry out a monthly Quality Review, including management metrics.
- Perform required activities in the Marken inventory system.
- Perform Process Control tasks in conditioning activities.
- Actively participate in training.
- Prepare weekly reports of temperature and humidity of the central monitoring system
- Write QA procedures, in compliance with regulatory and GMP aspects for the Buenos Aires deposit.
- To carry out revisions of translations of documentation to its version in Spanish.
- Act as a backup of the Quality Assurance Manager in your absence.
- Maintain the QMS in accordance with current regulations and in compliance with Marken quality standards.
Only shortlisted candidates will be notified.