Supply Operations Quality Associate

Pfizer Pfizer · Pharma · Bucharest, Romania

This role is a Supply Operations Quality Associate at Pfizer, focused on ensuring product quality and compliance with GMP/GDP regulations in the pharmaceutical supply chain. Responsibilities include managing quality investigations, handling product complaints, reviewing SOPs, assisting with CAPAs, and compiling performance indicators. The role requires a strong understanding of regulatory compliance and excellent organizational and collaboration skills. While experience with AI tools is a bonus, the core function of the role is not AI-related.

What you'd actually do

  1. Contribute to moderately complex projects by managing your time effectively and planning short-term work activities.
  2. Engage with stakeholders to address product quality complaints and ensure compliance with GMP/GDP during audits and inspections.
  3. Lead product quality investigations and follow up on actions to resolve compliance issues in the marketplace.
  4. Serve as a Subject Matter Expert and reviewer for Standard Operating Procedures (SOPs) and analyze inquiry data to identify trends.
  5. Assist with audit Corrective & Preventive Actions (CAPAs), review documentation related to repackaging and relabeling, compile Key Performance Indicator figures, and facilitate product-focused training sessions.

Skills

Required

  • High school diploma (or equivalent) with 8+ years of experience or associate’s degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience
  • Solid understanding of regulatory GDP/GMP compliance issues related to the manufacturing and distribution of medicinal products
  • Excellent organizational skills and the ability to juggle multiple priorities
  • Strong collaboration, communication, and interpersonal skills to work effectively with local, regional, and global colleagues
  • Proficiency in using System Application and Products, and Microsoft Office Suite
  • Technical expertise to handle complex quality assurance and control tasks

Nice to have

  • Relevant pharmaceutical experience, particularly in the use of Electronic Quality Management Systems
  • Supervisory experience
  • Knowledge of complaint processing systems and the ability to suggest modifications to enhance quality
  • Experience in facilitating product-focused training sessions
  • Ability to analyze and interpret data to identify trends and communicate findings
  • Excellent judgment and decision-making skills
  • Ability to mentor and review the work of other colleagues
  • Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

What the JD emphasized

  • Solid understanding of regulatory GDP/GMP compliance issues related to the manufacturing and distribution of medicinal products
  • Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.