Quality Assurance Batch Record Specialist
2 weeks ago
Company Overview:
Astrix is a leading global pharmaceutical organization dedicated to advancing treatment options for challenging diseases and conditions. We are currently seeking a skilled Batch Record Reviewer II to enhance our Quality Assurance team. This role presents a unique opportunity to contribute to innovative therapies and positively impact patient care.
Location: Not specified
Compensation: Competitive hourly rate
Position Summary:
The Batch Record Reviewer II operates autonomously to ensure quality assurance compliance across designated areas, adhering to current Good Manufacturing Practices (cGMPs) and Quality Control Systems. This position requires a high degree of independent judgment and the ability to swiftly identify, investigate, and resolve quality-related issues affecting products and processes.
Key Responsibilities:
- Maintain compliance with Standard Operating Procedures (SOPs) and regulatory requirements.
- Oversee change control processes effectively.
- Manage Corrective Action and Preventive Action (CAPA) plans and deviations.
- Conduct impact assessments for modifications to equipment and processes.
- Implement risk management strategies.
- Ensure thorough documentation and investigations meet all compliance standards, making critical decisions that may influence ongoing manufacturing operations.
- Authorize the release of equipment, systems, or areas.
- Provide quality oversight for complex change management systems, ensuring adherence to local SOPs and regulatory standards.
- Perform independent technical reviews of documentation during and after cGMP activities.
- Verify that all specifications are fulfilled and applicable requirements are satisfactorily completed.
- Confirm that all issues and documentation related to processes in the assigned area are resolved and compliant before advancing to subsequent steps.
- Analyze findings and report to relevant departments.
Qualifications:
- Bachelor's degree in Life Sciences or Engineering.
- Experience in a team lead or supervisory capacity.
- Strong attention to detail, organizational skills, and problem-solving abilities.
- Ability to prioritize tasks and work effectively under pressure.
- Proficient in MS Office applications (Word and Excel) and related software.
- Familiarity with SAP systems.
- Technical knowledge of manufacturing systems, methods, and procedures.
- Excellent written and verbal communication skills.
- Understanding of manufacturing processes.
Preferred Skills:
Experience in Quality Assurance, CAPA management, risk assessment, and regulatory compliance within a manufacturing environment is highly desirable.
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