Quality Operations Release and Redressing specialist

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 be responsible for evaluation, review and approval of validation master plan, protocols and reports. Your methodological approach will help us ensure compliance of our quality systems with company standards and government regulatory requirements. Your
problem-solving ability will help us troubleshoot validation problems for equipment and performance processes and conduct statistical analysis of testing results and process anomalies. Your documentation skills will guide the writing, review and approval of for validation process documents and technical reports related to equipment, products and processes.
As a Senior Associate, 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

• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Provide high level data analysis support for Quality Investigations.
• Comprehensive understanding of {Current} Good Manufacturing Practices {part of GxP} guidelines outlined in Code of Federal Regulations.
• Ensure compliance with latest Pfizer Quality Standards for validation and qualification activities.
• Manage routine Quality systems, such as Change Control, Quality Agreement, Documentation and Investigations.
• Coordinate and communicate all testing with affected functional groups and evaluate test results.
• Maintain Site Validation Master Plan Support regulatory audits through the preparation, defense and interaction with auditors in areas related to equipment, instrumentation, facilities and utilities.
• Provide expertise for trouble-shooting and resolution of issues related to equipment, instrumentation, facilities and utilities.
• Assess potential impact of changes to qualified systems Identify and implement validation best practices to continuously improve the site validation program Represent engineering validation on site or network teams as necessary.
• Support validation as a Subject Matter Expert during customer and regulatory audits for all areas of responsibility.
• Support product transfers/new product development, regulatory queries, cost improvement projects or Drug Product plant support for Cleaning Validation.
• Ensure integration of validation schedule in production schedule for implementation of validation activities and conduct validation deviations, participate in deviation investigations to identify root causes and define corrective and/or preventative actions. Support the unit where needed to assure due dates and customer needs are met.

Qualifications
Must-Have

• Bachelor's Degree
• 3+ years' experience
• Proven experience as a Program Manager
• Experience in {Current} Good Manufacturing Practices {part of GxP}
• Strong working knowledge of a variety of quality systems and processes
• Familiarity with information systems, such as Global Document Management System, System Application & Products and Quality Tracking System
• Strong verbal and written communication skills
• Ability to work in a team environment and manage projects independently

Nice-to-Have

• Master's degree
• Relevant pharmaceutical experience.
• Strong technical knowledge and experience with validation/qualification of pharmaceutical processes, equipment, utilities, facilities and/or computer systems is required, as related to sterile products and medical devices

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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