Quality Assurance Specialist
3 weeks ago
Job Description:
We are currently seeking a meticulous and experienced Quality Assurance Specialist with a strong background in Good Manufacturing Practice (GMP) and expertise in managing change controls across multiple studies simultaneously. As a Quality Assurance Specialist, you will play a crucial role in maintaining the highest standards of quality and compliance in our manufacturing operations.
Key Responsibilities:
- GMP Compliance: Ensure that all manufacturing processes and operations comply with Good Manufacturing Practice regulations and standards, including FDA, EMA, and other regulatory requirements.
- Change Control Management: Develop and implement robust change control processes to effectively manage changes in manufacturing procedures, equipment, and documentation for multiple studies concurrently.
- Quality Systems Management: Oversee and maintain the Quality Management System (QMS), including procedures, work instructions, and documentation, to ensure compliance and continuous improvement.
- Batch Record Review: Conduct thorough reviews of manufacturing batch records, ensuring accuracy, completeness, and compliance with regulatory requirements and company standards.
- Quality Risk Management: Identify, assess, and mitigate quality and compliance risks associated with manufacturing processes, materials, and equipment.
- CAPA Management: Lead investigations into quality issues, deviations, and non-conformances, and develop and implement corrective and preventive actions (CAPAs) to address root causes and prevent recurrence.
- Audits and Inspections: Prepare for and support internal and external audits and regulatory inspections, including conducting pre-audit activities, coordinating audit responses, and implementing audit findings.
- Training and Development: Provide training and guidance to manufacturing personnel on GMP requirements, change control procedures, and quality system processes.
Qualifications:
- Bachelor's degree in a scientific or engineering discipline; advanced degree preferred.
- Minimum of X years of experience in quality assurance within the pharmaceutical, biotechnology, or medical device industry, with a focus on GMP compliance.
- Strong understanding of Good Manufacturing Practice regulations and guidelines, including FDA CFR Part 210 and 211, EU GMP Annex 1, and ICH Q7.
- Proven track record in managing change controls for manufacturing processes and equipment across multiple studies concurrently.
- Excellent analytical, problem-solving, and decision-making skills.
- Detail-oriented with a commitment to accuracy and compliance.
- Effective communication and interpersonal skills, with the ability to collaborate cross-functionally.
- Experience with regulatory inspections and audits preferred.
- Certification in quality management (e.g., ASQ Certified Quality Auditor) is a plus.
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