Quality Assurance Associate

Pfizer Pfizer · Pharma · Vizag, India

Pfizer is seeking a Quality Assurance Associate in Vizag, India, to ensure the quality, safety, and efficacy of drug products. The role involves reviewing clinical and commercial drug batches, ensuring documentation meets specifications, identifying deviations, approving investigations, and overseeing change control. The associate will contribute to project tasks, maintain compliance with cGMP standards, and support regulatory inspections. This position requires a Bachelor's or Master's degree in Sciences/Pharmacy with relevant experience in the pharmaceutical industry and quality systems.

What you'd actually do

  1. Evaluate and review clinical and commercial drug batches to ensure quality.
  2. Ensure product and process documents meet established specifications through rigorous sampling and statistical process control.
  3. Identify and address deviations from manufacturing and packaging standards.
  4. Approve investigations and oversee change control activities to maintain compliance with configuration management policies.
  5. Contribute to project tasks and milestones, organizing work to meet deadlines.

Skills

Required

  • Bachelor's Degree in Sciences/ Pharmacy with Minimum 4-5 years in Pharma/ Biotech or Master's Degree in Sciences/ Pharmacy with Minimum 2 to 3 years in Pharma/ Biotech
  • Experience in the pharmaceutical industry and Quality administered systems
  • Sound knowledge of current Good Manufacturing Practices (part of GxP)
  • Ability to work effectively in a team environment, both within one's own team and interdepartmental teams
  • Effective written and oral communication skills

Nice to have

  • Experience at a manufacturing site.
  • Managing and writing deviations
  • Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management
  • Strong problem-solving skills
  • Ability to work independently and as part of a team
  • Excellent time management and multitasking abilities
  • Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance

What the JD emphasized

  • cGMP standards