Quality Operations Specialist

hace 7 días

Santiago de Chile Johnson & Johnson A tiempo completo

**We are searching for the best talent for Quality Operations Specialist (9 Months ) to be in Santiago, Chile**

**Purpose**:
Provide support to the quality area in order to implement, maintain and improve the Quality Management System of Johnson & Johnson Innovative Medicine., in order to comply with current local regulations, Quality Manual and Global Quality Standards. In addition, it will be responsible for the administration, operation, maintenance and improvement of the Quality System and the assurance of the company's processes in Distribution Center and the contracted external service vendors.

**You will be responsible for**:

- Ensure compliance with J&J Quality policies and local regulations within the Distribution Center.
- Keep Quality System documents up to date within the scope of the position.
- Collect information on service complaints, generating the corresponding analysis to take improvement actions.
- Record, support and follow up on the processes of Non-Conformities, CAPAs, Change Controls and Audits within the scope of the position. Implementation of action plans and follow-up.
- Support the implementation of the Annual Program of External Audits (suppliers) of all processes with the scope of the position.
- Manage and monitor the Quality metrics of the Distribution Center and Service Providers.
- Lead the work related to the Storage and Distribution of Temperature Control products.
- Ensure that there is a robust quality system that outlines the reception, quarantine, storage, release and distribution stages, ensuring the identity and traceability of the product throughout the supply chain.
- To support, when necessary, the operations of all sectors of the Corporation that are managed by Deliver.
- Manage the process of product release, return inspection, product entry and destruction maintenance and quarantine movements.
- Verify that products meet J&J quality requirements and local regulations before sale.
- Coordinate Recalls with the Distribution Center and other field actions when is necessary.
- Prepare, update and/or revise local documents in accordance with GMP and GLP, Quality Manual and J&J requirements.
- Report in a timely manner the escalation of serious problems that may affect the quality, safety and/or efficacy of the products.
- Ensure compliance with the procedures associated with the handling of products linked to claims and/or Adverse Events
- Approval for the release of Finished Products to the market
- Provide support in administrative management of purchasing for external suppliers, through the company's purchasing system.

**Qualifications**:
**Requirements**:

- Required level of education: Pharmaceutical Chemist, Biochemist or related careers in the health sector.
- At least 3 years of work experience in related areas.
- Up-to-date knowledge of local and GMP/GLP normative.
- Qualities such as self-management, proactivity and results orientation are required, Flexibility to change, Planning and Organization, Communication skills.
- Advanced English Level

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