Descrizione : Supply Chain External Quality Operations Specialist. Azienda : Pfizer. Posizione : Roma, Lazio
Pfizer is looking for a highly motivated resource to support the Supply Chain & External Supply Quality Operations department in the execution of the main quality activities in support to the Pfizer Pharma business.
Type of contract: Contratto di Somministrazione lavoro - 12 mesi
The key role of the SCESQ Specialist 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 SCESQ Specialist 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 SCEQO 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.
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 (PCOM). 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 SCMQO) 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:
Where required, 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.
Tracks the implementation of the identified actions within agreed timeframes.
Education in Science or Quality topics.
At least 1 year experience in Quality Operations related activities.
Quality and technical experience to manage expectations.
Makes sound and effective quality decisions under pressure.
Diplomatic in communication with internal and external customers.
Strong negotiation and effective communication skills.
Self-motivated individual who is comfortable with working independently
Able to lead and work effectively in cross-functional team & collaborate
English language communication verbal and written
Deadline to apply: February 9th.
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