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Pfizer

Makes cancer drugs, vaccines and other medicines

Validation and Compliance Specialist-GMP/Pharma Industry

Regulatory & Quality (Life Sciences)Posted on Nov 10
Full-timeFranklin, OH, USA$68.6k - $114.3k /yr

About the Job

Requirements

  • A high school diploma or equivalent with 8 or more years of experience, an associate’s degree with 6 or more years of experience, or a bachelor’s degree with at least 2 years of pharmaceutical industry experience.
  • Proven expertise in Good Manufacturing Practices.
  • Strong working knowledge of quality systems and processes.
  • Familiarity with information systems such as a Global Document Management System, System Application & Products, and Quality Tracking System.
  • Strong verbal and written communication skills.
  • Ability to work independently and in a team environment.
  • Ability to perform mathematical calculations and complex data analysis.
  • Ability to sit, lift, stand, and bend.

Responsibilities

  • Author, review, and/or approve validation master plans, protocols, and reports in compliance with company standards and regulatory requirements.
  • Perform validation activities in compliance with Good Manufacturing Practices and Validation Master Plan requirements.
  • Contribute to moderately complex projects, manage time effectively, and develop plans for short-term work activities.
  • Manage routine quality systems, including Supplier Quality Management, Change Control, Quality Risk Management, Documentation, Investigations, and Annual Product Review, and coordinate testing with functional groups.
  • Maintain the Site Validation Master Plan and support validation as a subject matter expert during customer and regulatory audits for areas of responsibility.
  • Support regulatory queries, cost improvement projects, and Cleaning Validation; integrate validation schedules into production and participate in deviation investigations.
  • Travel as required, with expected travel of less than 5%.

Desired Qualifications

  • Strong technical knowledge of validation or qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems.
  • Experience with quality management systems such as Veeva and Kneat.
  • Strong analytical and problem-solving skills.
  • Strong organizational and time management skills.
  • Ability to mentor and guide colleagues.
  • Experience in regulatory audits and compliance.
  • Experience using common artificial intelligence tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem-solving and productivity, with curiosity about improving outcomes and understanding responsible artificial intelligence practices, including risk management and ethical use.
  • Technical writing skills.

About the Company

Pfizer

Makes cancer drugs, vaccines and other medicines

Pfizer discovers, makes, and sells prescription medicines and vaccines for patients, doctors, and governments worldwide, with large businesses in vaccines, cancer, heart disease, and rare diseases. In 2020, its COVID-19 shot, developed with German partner BioNTech, became the first COVID-19 vaccine authorized in the United States. Its scientists find drug candidates and run clinical trials to prove they are safe and effective, and Pfizer then manufactures approved products in its own plants, earning most of its money from patented drugs before cheaper generic copies arrive. Pfizer was founded in 1849 as a chemicals business in Brooklyn and is based in New York City.

Company size
10,001+
Company stage
IPO
Headquarters
New York City, New York
Founded
1849

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