Quality Assurance Officer – Quality Operations At Pfizer - Science, Engineering Vacancy
Egypt - Remote
The Quality Officer (Logistic Quality Operations) is accountable for providing short term (day to day) operational quality support to Intercompany Operations and associated Quality Operations Management.
The Quality Officer will provide quality-operational support to ensure the supply continuity of critical Pfizer operations from manufacturing sites direct to customer and/or Distributor.
Within the Quality Operations Team, the Quality Officer will support to the compliance, logistics carrier quality operations management and operational counterparts with assigned duties.
Working both independently and as part of an operational quality team, the Quality Officer will work under supervision to support logistic and market operations.
The Quality Officer will have ‘real time’ interactions with Global network operations to support individual parcel shipments, associated processes, activities and associated quality management system records.
JOB SUMMARY - MAIN AREA’S OF RESPONSIBILITY / ACCOUNTABILITIES
Ensure that, as part of routine operation, shipping processes are conducted in a continuous GDP compliant manner, working to established Quality systems within Pfizer
Support the Quality Operations Manager and operational counterparts with assuring the technical resolution of network events and communications.
Participate in assigned process and procedural revision (as assigned) and improvement projects.
Manage in-transit incidents that occur within shipping operations
Provide Quality support for significant deviations or failure investigations with shipping operations that may impact inventory status change or require regulatory notifications
Supports changes within logistics operations
Supports regulatory or Pfizer-internal inspections at Intercompany Operations Logistics Centres and ensure appropriate Pfizer review/approval responses to Regulatory Agencies/Internal Audit functions including tracking of CAPAs within QTS.
Support the provision of metrics to ad-hoc, SQRT and QRM meetings and activities (as required).
KEY PERFORMANCE INDICATORS (KPI)
Comply with defined lead-times and escalate in time
Comply with and adhere to all procedures
Works according to relevant SOPs and WIs
Meet set departmental and individual objectives
Completes all required training in due time
Level of Education
Minimally BA/BS Science, Engineering or related technical discipline
Preferably 2-3 years in a GxP setting
Experience with external suppliers/contractors is preferred.
Experience with Transportation ideal but not mandatory
Strong English language (written and spoken) skills essential, multi-lingual skills highly beneficial
Advanced computer skills, MS Office and enterprise systems such as SAP, QTS, Documentum platforms
COMPETENCIES – PERSONAL CAPABILITIES
Knowledge of drug regulations and regulatory guidance of leading agencies (EMA, FDA, FAGG, MHRA and WHO) is a strong asset.
Ability to communicate effectively verbally and in writing, good negotiation and influencing skills.
Insight and understanding of shareholders needs and requirements.
Dynamic, flexible, enthusiastic and eager to learn.
Takes initiative and ownership to deliver on time without compromising on quality.
Ability to work under minimal supervision and in a team.
Able to demonstrate good planning and organisation skills.
Ability to apply technical knowledge and understanding to making appropriate and timely risk-based decisions.
High level of self- integrity and ethical conduct