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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 Business Development.
- Collaborate to provide GMPs requirements and documentation for tenders as part of the bundle of documents required to submit to local authorities.
- Ensuring distribution centers are ready to attend/support corporate Quality Audits and actively follow up for CAPA plans execution.
- As required by Technical Director, interact with Health Agencies to support and contribute with regulations that could impact products distribution.
- Actively participate in the Quality Council of the region on behalf of the Distribution Center.
- Actively participate in regional Quality projects in the region as well as SCM, HH, etc. projects, which require support from In‑market quality.
- Supports Repackaging Change Requests.
- Expense control/ budgeting.
- Master data change approval.

Main Activities for Import Testing (Chile)

- Coordinate sample collection and shipping to External Laboratories for analysis.




- Performing analysis requests for each batch of imported product.
- Maintain the supply of reference standards and chromatographic columns in laboratories.
- Request to Regulatory Affairs the submission of serial control requests, partial and/or total quality control exemptions to the Health Agency.
- Support external laboratories in case of any requirement regarding our products.
- Coordinates analysis priorities with external laboratories, according to priorities set in conjunction with Supply Chain Management.
- Collaborates with external laboratories to ensure adherence to health regulations and corporate policies.
- Coordinate the corresponding method transfers/ verifications for product launch.

Required Education, Experience and Skills

- Possess a combination of analytical/scientific skills to effectively manage and control all activities necessary to support a Quality Operations program governing external parties/partners that store and distribute Organon products.
- Broad knowledge of Distribution, External Supplier management, supply chain, Quality Assurance and at least notions of Quality Control.
- Competent in analyzing complex product, distribution, and transportation issues, and have demonstrated scientific problem‑solving capabilities.
- Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills.

Minimum Education Requirements

- Bachelor's degree in chemistry or pharmacy.
- Pharmaceutical Chemical Professional with no less than 5 years of relevant experience.
- Solid GDP and GMP knowledge.
- Advanced English Skill 90%+.

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Postúlate en Kit Empleo: kitempleo.cl/empleo/1djdms

📌 In-market Quality Sr. Specialist (Las Condes) (Chile)
🏢 Organon
📍 Chile