Quality Operations Release and Redressing specialist
Panama, Panama
hace 13 horas

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.

Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective quality assurance team.

You will support all daily activities related to quality logistics release, redressing and quarantine shipments activities within the Intercompany (IO) organisation.

You will be responsible to ensure the continuity of supply of materials both financial as physical and the compliant redressing of materials under the responsibility.

You will be responsible to ensure compliance with Good Distribution Practise standards, legal requirements and according to Pfizer Policy.

You will be in daily interaction with and will provide support to the Support functions to help the prioritisation and timely follow-up of identified discrepancies / issues and support releases within the supply chain.

Reach out to stakeholders across the network and be responsible to support complex investigations.

You will be responsible to ensure the Quality Systems are up to date and the site is inspection ready at any time.

You will be responsible for giving quality support to any improvement project within IO.

Your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables.

Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

  • Comprehensive understanding of Current Good Distribution Practices guidelines.
  • Ensure compliance with latest Pfizer Quality Standards for release and redressing activities.
  • Support the CoC / CoA and physical checks (if applicable) to allow batch disposition and support complex releases including psychotropics and narcotics
  • Daily batch release in SAP of batches within the network supporting the different locations
  • Prepare, review and maintain material and product specifications, and other GDP related documentation for products going through the organization.
  • Support and investigate / analyse the inventory changes in SAP
  • Provide support by daily issue resolution
  • Support the SSA for quality inventory management, administrative release, redressing and quarantine shipments processes
  • Verification of redressing requests
  • Review of documentation related to the redressing activities
  • Coordination of redressing activities with both Operations and vendor oversight functions
  • Ensure accurate maintenance of SOP / WI’S related to the tasks
  • Support the metrics reporting
  • Supporting change management activities relating to site compliance activities
  • Complete scheduled records and quality system tasks in a timely manner and in compliance with internal standards and EU GxP
  • Support inspection readiness for BOH inspections and external vendor audits
  • Collaborate with internal and external stakeholders to resolve quality issues and ensure compliance to EU GxP standards
  • Must-Have

  • Scientific background, or equivalent through operational experience in GDP environment.
  • 2+ years' experience
  • Fluent English written / spoken
  • Experience in Good Distribution Practices
  • Strong working knowledge of a variety of quality systems and processes
  • Strong verbal and written communication skills
  • Ability to work in a team environment and manage projects independently
  • Nice-to-Have

  • Expertise with complex supply chain is an advantage.
  • Familiarity with information systems, such as Global Document Management System, System Application & Products and Quality Tracking System
  • Work Location Assignment : Remote

    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

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