operational quality specialist.

As a Operational Quality Specialist, you will :

• Ensure cGMP compliance.
• Actively participate in the preparation of process performance qualification (PPQ) batches.
• Review and approve production batch records in both paper and electronic formats.
• Participate in the management/review/approval of deviations.
• Participate in the management/review/approval of CAPAs.
• Participate in the management/review/approval of change controls.
• Review and approve validation protocols and reports (CIP/SIP/EM/Thermal mapping).
• Ensure that identified risks/nonconformities are adequately addressed and reported on timely basis.

Here are the requirements as a Operational Quality Specialist:

• Bachelor's or Master's degree (biotechnology, pharmacy, etc.).
• Experience in a GMP environment.
• Good knowledge of quality management systems (QMS): Deviations, Change Control, CAPA.
• Good knowledge of biotechnology production processes (upstream and/or downstream and/or logistics (media/buffer).
• Good knowledge of cleaning processes (CIP/COP), sterilization (SIP), environmental monitoring, and thermal mapping of temperature-controlled areas.
• Excellent communication and teamwork skills.
• Autonomy and proactivity.
• Open-mindedness and flexibility in work organization.
• Good ability to manage stress and emergency situations.
• Good spoken and written English.