Pharmaceutical Quality Assurance Specialist
3 days ago
The Pharmaceutical Quality Assurance Specialist will oversee and manage documentation and processes essential for qualification activities related to pharmaceutical manufacturing and quality processes. This role ensures compliance with regulatory standards (e.g., FDA, EMA, and cGMP) and company policies.
Responsibilities:
- Author, review and/or approve procedures, reports, batch records, and other necessary documents to support ongoing manufacturing processes that follow regulatory standards.
- Responsible for Quality Operations oversight including real-time batch record review, response to deviations, and implementation of corrective actions.
- Provide Quality review and support for calibration and maintenance programs and ensure they are run following GMP regulation.
- Participate in or lead quality risk analysis.
Requirements:
- Minimum of 5-7 years of experience in a pharmaceutical or biotechnology environment.
- Strong knowledge of FDA, ICH, and other global regulatory requirements, including cGMP and GAMP5.
- Hands-on experience with qualification and validation of processes, facilities, equipment, utilities, and computerized systems.
Compensation:
This is a highly competitive position with an estimated salary range of $90,000 - $120,000 per year, depending on experience. Benefits include comprehensive health insurance, retirement plan, and generous paid time off.
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