Associate - Quality Assurance

2 days ago

Visakhapatnam Andhra Pradesh, India Pfizer Full time

Use Your Power for Purpose

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard. Your role is crucial in maintaining this commitment and driving forward our mission to improve patient outcomes.

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.
- 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 with any years of experience, or an Associate's degree with 4 years of relevant experience, or a high school diploma (or equivalent) and 6 years of relevant experience
- 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

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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