Operations Trainee

hace 3 semanas

Santiago de Chile Emprego CL A tiempo completo

**Overview of opportunity**: Give support to Operations Chile to accomplish CSL Behring's requirements from Regulatory Affairs and Quality Assurance that includes the support on the monitoring product imports on the corresponding local regulatory and quality activities prior to the market release, the local logistic activities quality related, the provision of technical documentation required in tenders processes and some specific pharmacovigilance tasks.

**Key Responsibilities**:
**Collaborate in the following quality and regulatory activities of products importation**:

- ** Manage the Serial Control / Exemption Control and Quality Control Exemption process requested for all product batches to the National Control Laboratory of ANAMED throughout the process under Operations Manager supervision. This includes the requests in the HA website by providing the quality documentation received from each manufacturing site.**
- ** Request the import testing from the Third Party Laboratory, M.Moll and provide sample sending instructions to the CSLB Chile Sale Administrative.**
- ** Upon arrival of imported batches in Chile, oversight of transport verification for compliance with required conditions during shipment of products from manufacturing sites to recipient; provide temperature sensor to CSL Behring Global Quality.**
- ** Collaborate in the maintenance and update of virtual folders of product/batches importations**

**Under Operations Manager supervision, collaborate in the handling of product complaints and deviations within the corresponding deadlines in the CSLB Quality Management System.**

**Support the quality oversight for local distribution temperature requirements compliance of refrigerated products from 3PL (local logistic partner) to customers; cooperate in the corresponding quality activities in case of temperature excursions, such as deviations processing and the communication with affected customers.**

**Technical support for tenders: cooperates with the provision of regulatory and quality documentation required in tenders processes.**

**Serve as Pharmacovigilance back-up in case of Local Safety**
**or** Deputy Safety officers' absence. The activities are limited to some specific of revision and internal processing. The trainee will not be involved in the direct communication with the Health Authority.

**Qualifications**:

- ** Pharmacist graduate student (essential)**

**Experience**:

- ** No experience is required for trainee position**

**About Us**

**Our Benefits**

We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL.

**About CSL Behring**

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

**We want CSL to reflect the world around us**

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.

**Do work that matters at CSL Behring

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