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.

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.

Last updated : 2024-05-30