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Panama Scmoq Officer
hace 1 mes
JOB FOCUS
The key role of the SCMOQ Officer is to support Panama SCMOQ Manager on establishing and maintaining an appropriate and sustainable Product Quality System and Quality Culture at Logistic Service Provider (LSP) and Panama Pfizer Country Office (PCO) 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 SCMOQ 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 (CITI) management and for interacting with the relevant local stakeholders (such as Regulatory Affairs, Medical, other business units) and Pfizer Global Supply (PGS) on such issues.
Also, the SCMOQ Officer will monitor the product quality and compliance activities at the LSP doing at minimum 1 visit per week to their facility located in Colon city, to ensure current regulatory expectations are met, and facilitate internal and regulatory GMP inspections. Quality contact for product quality compliance issue and resolution. The position will act as the Panama SCMOQ Manager Backup for the quality activities in Panama.
JOB SUMMARY - MAIN AREA’S OF RESPONSIBILITY / ACCOUNTABILITIES
The responsibilities of the SCMOQ Officer are guided by Pfizer Quality Standards (PQS) - which are translated into local SOPs / GSOP- and by local regulations. Scope of the responsibilities: All Pfizer Products. Ensures full compliance of the Panama LSP with government and Pfizer policies, procedures, guidelines and regulations.
SCMOQ 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, Intercompany Operations (IO) representative, 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
- Support the complaints’ intake process from the LSP.
- Develops and issues responses to complainants in a timely manner when it is applicable.
- Notification to Management
- Support the Notification to Management process and/or a notification to Regulatory Authorities, in/for the required market(s).
- Attends Area Quality Review Team (AQRT) meetings, when it is applicable, to provide the local perspective on the issue at hand. Provides AQRT Executive Summary for issues originating under the responsibility of the Contractors or SCMOQ 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. Act as the Change Control processs Owner.
- Ensures that all relevant PGS colleagues are appropriately trained in the Product Quality SOPs / GSOPs.
- Support SCMOQ 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 SCMOQ 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 Supply.
- 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
