The Quality Person is the local support for all quality matters including the implementation of quality procedures, standards and specifications across all activity, auditing to ensure compliance and making sure corrective actions are taken to minimise future occurrences.
Responsibilities:
- Implement global QA strategy locally that outlines goals for activities such as building effective QA
- procedures, audit standards and ensuring consistent application, making sure appropriate corrective
- actions are carried out to minimise future occurrences.
- Implement local P, SOP, WI, SF and other documentation that provides guidance and clarity on
- procedures concerning clinical trials logistics.
- Ensure that all operations are performed according to the applicable standard procedures and
- working instructions at the appropriate location.
- Ensure improvement of effective Quality systems and procedures locally.
- Participate in review and approval of local and global SOP, WI, SF and other documents, that have
- influence on the Oximio Quality system that are aligned to the Oximio goals and values.
- Control of update local SOP, WI, SF in a timely manner.
- Informing Companys personnel about new documents issue/ documents update.
- Conduct training on QMS procedures for new employees and GxP training.
- Lead clients external audits, providing documentation required during external audits and
- assessment, providing response concerning observations occurred during external audit.
- Implementation and control of compliance with ISO 9001 and GxP requirements.
- Implementation and control of compliance with local and global legislation requirements.
- Conduct audits of suppliers (if necessary).
- Evaluate and approve suppliers ensuring that they are aligned to established Quality standards.
- Preparation for ISO 9001 certification and lead further periodical inspections (if necessary).
- Participation of suppliers. audits (if necessary), control of suppliers. audits conducting and Supplier evaluation.
- Implement and maintain regular review and effectiveness estimation of Quality system locally.
- Participate in Management Review process, preparing reports on functioning of QMS processes
- Maintain QMS documentation in electronic.
- Provide finding and recommendations locally concerning QMS processes.
- Higher education Experience
- Experience in GWP/GDP pharma experience is mandatory
- Knowledge and experience in global, multi-site, multi-cultural organisation
- Excellent national and international QA systems experience
