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The Position
Responsible for the local product release process (and batch disposition in general) in accordance with local regulations and Organon requirements for local market under its responsibility.
Responsibilities
- Responsible for coordinating local recall activities.
- Oversight the outsourced Distribution Centers ensuring full compliance with local regulations, Organon policies and guidelines and terms of the Quality Agreement.
- Responsible for the development, updating and maintenance of Quality Agreements.
- Document all quality processes and ensure that internal GDPs/GMPs processes are properly documented at distribution centers.
- Conduct periodic and unplanned inspections of products received from our suppliers that allow the detection of quality deviations or non-conformities in products.
- Ensure proper management of release, rejection, returns and recall process at distribution centers.
- Ensure that standard operating procedures (SOPs)/work instructions/job aids in distribution are in accordance with internal GDPs/GMPs procedures and local regulatory requirements.
- Coordinate and/or investigate deviations detected in products or documents during shipments, storage, and distribution.
- Ensure proper cold chain handling during the reception, storage, and local distribution of products.
- Provide technical support to external customer investigations (PQCs) when required by DPOC (point of contact), CHU (complaint handling unit) or CIU (research site).
- Collaborate with investigations for health authorities when local regulation requires it and DPOC requests technical support.
- Support proper cold chain management and support the evaluation of your local excursions.
Responsible for product disposition during temperature excursions in the local distribution process.
- Responsible for performing due diligence for new suppliers identified by procurement COE intended to support GMP/GDP activities.
- Responsible for supporting GDPs activities for Busin
Postúlate en Kit Empleo: kitempleo.cl/empleo/1cqdhj