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In-market Quality Sr. Specialist

hace 3 semanas

Las Condes, Chile Organon A tiempo completo

**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.

Mínimum 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%+

**Secondary Job Description**

**Who We Are**:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives w