Quality Assurance Analyst
hace 3 semanas
Position Overview
The Quality Assurance Analyst will be responsible for overseeing and executing product release processes to ensure adherence to regulatory standards and global best practices. This role will primarily focus on Sterile Manufacturing Operations, collaborating with QA experts to manage release activities, sterile production, documentation, data integrity, and compliance with regulations.
Key Responsibilities
- Product Release Management: Supervise and implement product release activities in alignment with regulatory guidelines and organizational standards.
- Sterile Manufacturing Oversight: Provide quality assurance support for sterile manufacturing processes, including aseptic techniques, sterilization methods, and environmental controls.
- Quality Documentation: Oversee and assess quality-related documentation, such as batch records, standard operating procedures (SOPs), validation protocols, and reports.
- Data Integrity Assurance: Establish and uphold data integrity measures to guarantee the accuracy, completeness, and reliability of quality data.
- Compliance Monitoring: Keep updated on regulatory requirements and industry best practices pertaining to quality assurance.
- Quality Management Systems: Assist in the development, implementation, and maintenance of effective quality management systems, including deviation management, change control, CAPA, and risk management processes.
- Audit Support: Facilitate internal and external audits and regulatory inspections.
- Process Improvement: Identify and recommend opportunities for enhancing processes and quality standards.
Skills & Qualifications
- Proven experience in a quality assurance role within the pharmaceutical or regulated sectors.
- In-depth operational knowledge of pharmaceutical manufacturing processes, particularly in sterile production.
- Expertise in documentation management and principles of data integrity.
- Understanding of regulatory standards, including cGMP, FDA regulations, and international guidelines.
- Strong communication, problem-solving, and decision-making abilities.
- Capability to work both independently and collaboratively in a fast-paced environment.
- Previous involvement in regulatory inspections and audits is preferred.
Benefits
- Work within an organization that values diversity and inclusion, believing that varied perspectives lead to better outcomes.
- Competitive compensation package with performance-based bonuses and comprehensive benefits.
- Flexible hybrid work culture.
- Opportunities for personalized career development through feedback loops.
- Join a growing company that empowers employees to take ownership and accountability from day one.
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