Supply Chain Quality Officer

hace 2 semanas

Panamá, Panamá Pfizer A tiempo completo

JOB FOCUS

The key role of the Supply Chain Quality (SCQ) Officer is to support SCQ Panama Management on establishing and maintaining an appropriate and sustainable Product Quality System and Quality Culture at Logistic Service Provider (LSP) and Panama Pfizer Office in order to ensure compliance with Pfizer and Regulatory Authority expectations. Provides support to the Panama Quality Operations Department with the implementation, performance and monitoring of Product Quality and Compliance (GMP/GDP) Quality Systems and compliance related initiatives within the Logistic Service Provider.

In addition, the SCQ Officer will be the main point of contact for the investigation and resolution of product quality issues discovered or originating at the LSP, product complaints management and for interacting with the relevant local stakeholders (such as Regulatory Affairs, Medical, other business units) and PGS on such issues.

Also, the SCQ Officer will monitor the product quality and compliance activities at the LSP, to ensure current regulatory expectations are met, and facilitate internal and regulatory GMP inspections. Quality contact for product quality compliance issue and resolution.

JOB SUMMARY - MAIN AREA’S OF RESPONSIBILITY / ACCOUNTABILITIES

The responsibilities of the SCQ Officer are guided by Pfizer Quality Standards (PQS) - which are translated into local SOPs / GSOP- and by local regulations. Scope of the responsibilities: Panama Pharma Consumer.

SCQ Officer responsibilities may include some or all of the following, depending on the scope of PGS activities in the country

1. Resolution of Product Quality Compliance Issues
- Deviation Management
- Management Investigates, together with appropriate local functions, deviations from Product Quality and Compliance requirements that occur within the responsibility of the contractors, IO LALC, PCO Panama and tracks preventive/corrective actions. Local investigations may relate to product damage, artwork and labeling errors, counterfeits, temperature excursions during transport or issues with contract manufacturers or logistics service providers etc.
- Provide trends and updates to PCO leadership.
- Product Complaint handling
- Manages the intake of complaints from the LSP.
- Develops and issues responses to complainants in a timely manner.
- Notification to Management
- Informs PGS QO Management of significant deviations and complaints.
- Attends Area Quality Review Team (AQRT) meetings, to provide the local perspective on the issue at hand. Provides AQRT Executive Summary for issues originating under the responsibility of the Contractors or SCQ Panama Quality System.
- Ensures the local implementation of actions identified during AQRT meetings, e.g. recalls, communication with Regulatory Agency, local corrective/preventive actions (CAPA).

2. Product Quality System
- Ensures timely implementation of all applicable Product Quality SOPs / GSOPs (issued by QO) within PGS.
- Ensures that all relevant PGS colleagues are appropriately trained in the Product Quality SOPs / GSOPs.
- Support SCQ Panama Management on monitoring key quality performance indicators, evaluates and highlights any significant trends and identifies actions.
- Conducts internal assessments to evaluate compliance with product quality systems & processes, and to identify improvement opportunities.
- Notify SCQ Panama Management on any relevant issue or observation identify during internal assessment execution.
- Assess new quality system/local regulatory requirements and adjusts/enhances local systems and processes when required.

3. Local Product Disposition
- Where required, performs local release of imported products, reconditioned products and packaging materials in compliance with the applicable local regulations and local procedures, prior to distribution/sale within country.
- When required, defines requirements under which returns can be taken back to saleable stock and supports local actions, in cooperation with logistics and distribution center.

Administrate material status within the distribution network. This includes:

- Coordinate or Perform the inspection of products entering the Logistics Center, in accordance with the requirements of GSCPM.
- Ensure that products comply with the current release technical documentation.
- Ensure compliance and disposition of products according to existing arts, regulatory and quality requirements.
- Inspections of product and materials to approved specifications and provide final disposition status.
- Review Technical Specification sheets, for approval of reconditioning instruction to LSP.

Support the Panama SCQ Manager to lead or assist in root cause investigation in the event of a non-conformance, related to any of the regulatory areas described above. Present formal notifications of significant issues to senior management and Quality Review Teams.

4. Inspections and Internal Audit:

- Support Panama SCQ Management on preparation and

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