Role Description
The key role of the Supply Chain Quality Operations Specialist is to 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.
Also, the SCQ Specialist 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 Specialist are guided by Pfizer Quality Standards (PQS) - which are translated into SCQ PQ SOPs- and by local regulations.
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.
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
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
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/ESQ 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
Summary Of Skills
Has an appropriate education in science or quality topics.
2 years experience in Quality Operations & Manufacturing and Regulatory is advantage.
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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