ROLE DESCRIPTION
The key role of the Supply Chain Quality Operations Officer (SCQO) 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.
MAIN ACCOUNTABILITIES
‎1. Resolution of Product Quality Compliance Issues
Deviation Management (in conjunction with the PGS 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 (CITI).
* Tracks complaint responses
* 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 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 require.
‎3. 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
‎4 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.
‎5. Oversight of local Repackaging and Relabeling Operations
* Regular visits to Pfizer Distributions center and local Logistics service providers "LSPs) to ensure adherence to Pfizer Quality Systems.
* Ensures relabeler / repackager has been assessed and approved
* Obtains regulatory approval of the repackaging/relabeling activity, if required under the local regulations
* Informs the releasing site of the repackaging/relabeling activity
* Reviews documentation related to the repackaging/relabeling operation
* Releases the repackaged/relabeled product
‎6. 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.
* ‎3-‎5 years' experience in Quality Operations & Manufacturing and Regulatory 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

Work Location Assignment: Flexible

Pfizer is an equal opportunity employer and complies with all applicable equal
employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control

LI-PFE