Supply Chain Quality Specialist-Saudi Arabia Market, Cairo - Pfizer

ROLE DESCRIPTION

The key role of the Supply chain Quality specialist (SCQ) 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.

In addition, the SCQ will be the main point of contact for the investigation and resolution of all product quality issues discovered or originating in the Pfizer Country Office (PCO) and for interacting with the relevant local stakeholders (such as Regulatory Affairs, Medical, BU) and PGS on such issues.

Also, the SCQ will monitor the product quality and compliance activities at the PCO, to ensure current regulatory expectations are met, and facilitate internal and regulatory GMP inspections.

MAIN ACCOUNTABILITIES

The responsibilities of the SCQ are guided by Pfizer Quality Standards (PQS) - which are translated into SCQ PQ GSOPs- and by local regulations.  

1. Resolution of Product Quality Compliance Issues

Deviation Management (in conjunction with the Manufacuring Quality Operations):

• Investigates, together with appropriate local functions, deviations from Product Quality and Compliance requirements that occur within the responsibility of the country organization and agrees 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.
               
  Product Complaint handling:

• Manages the intake of complaints from the local market, assigns class and criticality to the product complaint and forwards them to the appropriate investigating PGS /Contractor Site via the global complaints management system (PCOM).
• Tracks complaint responses
• Develops and issues responses to complainants in a timely manner.

           

           

Notification to Management

• Informs Manufacturing QO Management of significant deviations and complaints.
• Attends Area Quality Review Teams (AQRT) meetings, as principal PCO representative, to provide the local perspective on the issue at hand. Provides AQRT Executive Summary for issues originating under the responsibility of the PCO.

• Ensures the local implementation of actions identified during Area Quality Review Team (AQRT) meetings, e.g. recalls, communication with Regulatory Agency, local corrective/preventive actions

2. Product Quality System

• Ensures timely implementation of all applicable Product Quality SOPs (issued by SCQ) 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 assess compliance with product quality systems & processes, and to identify improvement opportunities.   
• Assess new quality system/local regulatory requirements and adjusts/enhances local systems and processes when required

3. Local Product Disposition

• Performs local release of imported products, in compliance with the applicable local regulations and local procedures, prior to distribution/sale within country.
• Defines requirements under which returns can be taken back to saleable stock and supports local actions, in cooperation with logistics and distribution center

4. Inspections and Internal Audit

• Participate in 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
  5. Local Contractor Quality Oversight

• Regular visits to affiliate contractors (Manufacturing sites/LSP/Wholesalers) to ensure implementation of Pfizer Quality system.
• Develops, negotiates and maintains up to date Quality Agreements with GMP/GDP contractors involved in manufacture, repackaging, laboratory testing or 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 Manufacturing Supplier Quality Assessment (MSQA) audit process at the contractor. Helps to define appropriate action plans for improvement and follow-up and communicate action closures.
• Conduct Quality Qualification for all Pfizer GxP related suppliers .

6.   Quarantine Alert Notices (where non-Pfizer warehouses are used to receive and store product in the country)

• Receives and manages Quarantine Alert Notices (QAN) received from Primary Logistic locations
• Establishes with LSP if product lots remain at the site and, if so, alerts the LSP to place the product on hold. 
• Informs the Primary Logistic Location and PGS Site/COQA of quantity of product still within Pfizer control and follows further instructions regarding product disposition.

7. Oversight of local Relabeling Operations

• Regular visits to Pfizer Distributions center and local Logistics service providers “LSPs) to ensure adherence to Pfizer Quality Systems. 
• Ensures relabeler has been assessed and approved
• Obtains regulatory approval of the relabeling activity, if required under the local regulations
• Informs the releasing site of the relabeling activity
• Reviews documentation related to the relabeling operation
• Releases the repackaged/relabeled product

8. Development and Maintenance of Consistent Quality Culture

• Collects data and metrics on PCO quality performance and communicates this to PCO Management. This may involve a regular Management Quality Review process.
• Provides ongoing education on Quality to relevant PCO functional groups, to increase awareness and understanding of requirements and enhance the Quality Culture

SUMMARY OF SKILLS

• Has an appropriate education in science or quality topics.
• Minimum 5-year experience in Quality Operations & Manufacturing is required.
• Has appropriate quality and technical experience to management expectations
• Makes sound and effective quality decisions under pressure.
• Diplomatic in communication with internal and external customers.
• Show strong negotiation and effective communication skills. Is influential
• Self-motivated individual who is comfortable with working independently
• Able to lead and work effectively in cross-functional team & collaborate
• Computer literate
• English language communication verbal and written

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