NOUS RECHERCHONS UN QA ASSISTANT

QA assistant

In relation to the activities carried out by PDC*line Pharma, the person occupying the position of QA and logistics assistant has the following responsibilities:
- Participate to the development and maintenance of the Quality Management System at
PDC*line Pharma;
- Ensure strict application of cGMP requirements during QC analysis of investigational medicinal
products batches;
- Communicate with PDC*line Pharma other teams and/or suppliers for quality purposes;
- Identify, write and review SOPs and other type of QMS documents;
- Review and approval of master batch record and completed batch record in SmartReg;
- Manage the internal and the external distribution of PDC*line Pharma’s QMS documents;
- Support the Quality Manager in the process of Batch Release;
- Support the continuous improvement of PDC*line Pharma QMS;
- Manage OOS, Deviation CAPA and Change Control;
- Assist in carrying out internal quality audits on PDC*line Pharma process and QMS;
- Perform investigation, corrective action and follow up on received complaints;
- Participate in annual quality reviews;
- Participate in audits organized by the competent authorities;
- Participate in the management of suppliers and subcontractors (selection, qualification and
complaints);
- Assist in carrying out external quality audits of suppliers and subcontractors
- Ensure the organization of staff training, provide training related to quality system and verify its
correct implementation;
- Manage the identification, IQ/OQ, maintenance, qualification and cleaning of equipment;
- Maintain up-to-date the equipment database;
- Review material specifications and monitor storage conditions for materials;
- Meet defined timelines and execution of tasks according to quality priorities;
- Ensure additional missions in the field of her/his skills.

The position of QA and logistics assistant requires the following skills:
- Scientific higher education;
- Further training and experience in quality management;
- Experience in the biopharmaceutical sector;
- Knowledge of quality tools;
- Knowledge of GMP guidelines;
- Knowledge of the activities of PDC*line Pharma;
- Knowledge of English (comprehension of English text);
- Good organization and communication skills.

We offer :
• A diversified position with responsibilities within a fast-growing start-up.
• The opportunity to join a human-sized, dynamic and professional environment.
• A permanent contract and an attractive salary package in line with your experience.

Interested?
Please apply by sending your CV and cover letter via e-mail to the attention of Dominique Rodrigues - HRD (d.rodrigues@pdc-line-pharma.com).
Your application will be treated as confidential.