Executive-Quality Assurance
- India
- Permanent
- Full-time
- 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.
- Handling and management of supplier quality.
- In process Quality checks in manufacturing area
- Handling of quality documentation system
- Handling of validation and qualification activities.
- 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.
- Bachelor's degree (B.Phar./M.Pharm)
- 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
- 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