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    Quality Operations Release And Redressing Specialist

    Pfizer
    3+ years
    Not Disclosed
    Philippines
    10 Jan. 24, 2025
    Job Description
    Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Quality Operations Release and Redressing Specialist

    Location: Makati City, Philippines
    Job Type: Full-Time
    Posted: 1 Day Ago
    Job ID: 4923297

    Purpose and Values

    At Pfizer, we are relentlessly pursuing breakthroughs that change patients' lives. Every day, we innovate to make the world a healthier place. Our purpose is driven by a set of core values that guide us in achieving both our goals for patients and the means by which we accomplish them.

    Role Overview

    We are seeking a Quality Operations Release and Redressing Specialist to join our team. In this role, you will be responsible for ensuring the compliance of Pfizer’s quality systems with company standards and government regulatory requirements. This includes evaluating, reviewing, and approving validation master plans, protocols, and reports. You will contribute to quality investigations, troubleshooting validation issues, and ensuring the successful execution of validation processes for equipment, products, and processes.

    Key Responsibilities

    Validation and Documentation Management

    • Evaluate, review, and approve validation master plans, protocols, and reports.
    • Ensure compliance with Pfizer’s Quality Standards for validation and qualification activities.
    • Guide the creation, review, and approval of validation process documents and technical reports related to equipment, products, and processes.
    • Manage and maintain the Site Validation Master Plan.

    Quality Systems and Investigations

    • Provide high-level data analysis support for quality investigations.
    • Manage routine quality systems such as Change Control, Quality Agreements, Documentation, and Investigations.
    • Ensure the integration of the validation schedule with the production schedule for validation activities.

    Troubleshooting and Issue Resolution

    • Provide expertise for troubleshooting and resolving issues related to equipment, instrumentation, facilities, and utilities.
    • Assess the potential impact of changes to qualified systems and identify best practices for validation.
    • Participate in deviation investigations to identify root causes and define corrective/preventative actions.

    Audit and Compliance Support

    • Support regulatory audits by preparing, defending, and interacting with auditors regarding equipment, instrumentation, facilities, and utilities.
    • Act as a Subject Matter Expert during customer and regulatory audits for all areas of responsibility.

    Project Management and Coordination

    • Contribute to the completion of complex projects, manage time to meet targets, and plan activities within a team.
    • Represent engineering validation in site or network teams as required.
    • Support product transfers, new product development, regulatory queries, and cost improvement projects.

    Required Qualifications

    Education and Experience

    • Bachelor's degree in a related field.
    • At least 3 years of experience in quality operations, validation, or related areas within the pharmaceutical industry.
    • Proven experience as a Program Manager with strong working knowledge of quality systems and processes.
    • Familiarity with Good Manufacturing Practices (GMP) and GxP guidelines.
    • Strong verbal and written communication skills.
    • Ability to work both independently and in a team environment.

    Technical Skills

    • Experience with information systems, such as Global Document Management Systems (GDMS), System Application & Products (SAP), and Quality Tracking Systems (QTS).
    • Strong technical knowledge in validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems.

    Nice-to-Have Qualifications

    • Master’s degree in a relevant field.
    • Relevant experience with sterile products and medical devices.
    • Experience with validation/qualification in pharmaceutical processes, equipment, and computer systems.

    Work Location and Conditions

    • This role is a remote work opportunity.

    What We Offer

    • A dynamic and collaborative work environment.
    • Opportunities for career growth and professional development.
    • Competitive compensation and benefits packages.
    • The chance to contribute directly to improving the lives of patients worldwide.

    Application Process

    Pfizer is an equal opportunity employer and complies with all applicable employment laws in the jurisdictions where it operates. We encourage candidates from all backgrounds to apply. If you are passionate about advancing pharmaceutical operations and making an impact on global healthcare, we welcome your application.

    Pfizer is committed to fostering an inclusive workplace where all employees can thrive.

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