Affiliate Quality Operations Manager
hace 3 días
The key role of the Pfizer Supply Chain Quality Manager (SCQ M) in Uruguay & Paraguay is to establish and maintain an appropriate and sustainable Product Quality System and Quality Culture at the Pfizer Country Office (PCO) in order to ensure compliance with Pfizer and Regulatory Authority expectations.
- SCQ M is the main point of contact_ _for the investigation and resolution of all product quality issues discovered or originating in the PCO, as well as for interacting with the relevant local stakeholders (such as Regulatory Affairs, Medical, Global Supply Chain, Commercial, Customer Service, etc.) and PGS sites on such issues. The SCQ M is the Quality authority in the PCO.
- Monitors the product quality and compliance activities at the PCO (including AMTE), to ensure current regulatory expectations are met, and facilitate internal and regulatory GMP inspections.
- Provides support to Business in Quality systems and issues resolutions.
- Responsible for the LSPs oversight in Pfizer Uruguay and Paraguay in GMP, GDP and GSP.
- Responsible for local third party laboratories oversight (microbiology and physicochemical) in Uruguay and Paraguay.
- Responsible for local third party re-packaging materials printer oversight in Uruguay.
- Responsible for all GMP local third parties suppliers in Uruguay and Paraguay.
- SCQ Manager is the Market Leader for Uruguay & Paraguay SCQ Department.
**MAIN RESPONSIBILITIES**:
Resolution of Product Quality Compliance Issues
- Deviation Management
- Product Complaint handling
- Notification to Management
Product Quality System
- Ensures timely implementation of all applicable Product Quality SOPs within the PCO.
- Ensures that all relevant PCO colleagues are appropriately trained in the Product Quality SOPs.
- Monitors key quality performance indicators, evaluates and highlights any significant trends and identifies actions.
- Conducts internal assessments to ensure compliance with product quality systems & processes, and to identify improvement opportunities.
- Assesses new quality system/local regulatory requirements and adjusts/enhances local systems and processes when required.
- Ensures applicable global systems are deployed timely to sustain quality policies in the PCO
Local Product Disposition
- Supervises local release of imported products, in compliance with the applicable local regulations and local procedures, prior to distribution/sale within Uruguay & Paraguay.
- Defines the process for batch release including Pfizer and local requirements.
- Oversights the local quality control tests for product disposition in alignment to applicable laws in Uruguay.
- Investigates OOS & non conformities during test in third parties laboratory (assays, dissolution, purity, uniformity of content and others as applicable).
- Assures availability of reference standards, samples and reagents at local laboratories for quality control tests in a timely manner.
- Defines requirements under which returns can be taken back to saleable stock and supports local actions, in cooperation with logistics and distribution center
Inspections and Internal Audit
- Leads preparation and coordination of Regulatory Agency and internal Pfizer inspections of Product Quality and Compliance (GMP/GDP) activities at the PCO.
- Works with local functions to define an appropriate action plan to address the inspection/audit observation.
- Tracks the implementation of the identified actions within agreed timeframes.
- Supports the Technical Director (Regulatory Affairs Manager) responding BoH queries when applicable.
Local Contractor Quality Oversight (laboratories, LSPs, printer, storage of GMP documents, etc).
- Develops, negotiates and maintains up to date Quality Agreements with GMP/GDP contractors involved in manufacture, repackaging, laboratory testing and activities at Logistics Service Providers.
- Oversees quality operations at contractors, which includes but is not limited to:
- Contractor Assessment and Approval: ensures all GMP/GDP contractors have been formally assessed and approved.
- Deviation Management: evaluates the impact of all significant deviations affecting Safety, identity, strength, purity & quality (SISPQ), generated at the contractor and agrees corrective actions. If necessary, initiates the “Notification to Management” process.
- Quality System Support: visits the contractor to assess quality systems, review quality performance and agree action plans to ensure continuous improvement. Include quality reviews during Business Review Meeting (BRM), where existing.
- Issue and review Metrics: Periodically assess the overall quality risk associated to the contractor.
- Act on adverse trends in order to improve contractor quality and compliance performance.
- Facilitates the Pfizer global audit process at the contractors as the point of contact. Helps to define appropriate action plans for improvement and follow-up and communicate action closures.
Analytical Method Transfer Exercis
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