Quality Assurance Associate (Pfizer)

Roles and Responsibilities

What You Will Achieve

In this role, you will:

• Evaluate and review clinical and commercial drug batches to ensure quality.

• Ensure product and process documents meet established specifications through rigorous sampling and statistical process control.

• Identify and address deviations from manufacturing and packaging standards.

• Approve investigations and oversee change control activities to maintain compliance with configuration management policies.

• Contribute to project tasks and milestones, organizing work to meet deadlines.

• Learn and apply basic team effectiveness skills within the immediate work team.

• Make decisions within limited options to resolve basic problems under supervisor's direction.

• Ensure manufacturing and packaging records conform to Pfizer policy and cGMP standards.

• Maintain inspection readiness, support regulatory and customer inspections, and improve quality assurance systems.

• Assist manufacturing/packaging staff in real-time compliance error detection and resolution, and lead or participate in Quality Risk Management assessments.

Here Is What You Need (Minimum Requirements)

• 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

Bonus Points If You Have (Preferred Requirements)

• 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