QA Manager

Introduction:

A highly experienced Quality Assurance and Validation Consultant with 26 years of expertise in quality management systems, regulatory compliance, and validation processes in the pharmaceutical, biopharmaceutical, and medical device industries. Proficient in designing, implementing, and maintaining QMS, ensuring compliance with ISO 9001, ISO 13485, cGMP (21 CFR 211, 820, 600), and EU regulations. Expertise in validation of equipment, computer systems, and sterilization methods, along with risk management and continuous improvement methodologies. Extensive experience in document auditing, protocol development, process validation, and post-market surveillance. Skilled in design control, supplier quality management, and process improvement in manufacturing environments. Adept at leading CAPA investigations, remediation activities, and compliance audits. Strong knowledge of aseptic processing, cleaning validation, and sterility assurance. Hands-on experience in Good Distribution Practices (GDP) and serialization requirements. Proven ability to manage cross-functional teams and regulatory submissions in highly regulated industries.

Responsibilities:

• Developed, implemented, and maintained Quality Management Systems (QMS) to comply with ISO 9001, ISO 13485, and cGMP regulations.
• Performed audits, gap analyses, and risk assessments to identify compliance issues and implement corrective actions.
• Led validation efforts for equipment, facilities, utilities, and computer systems, ensuring compliance with regulatory standards.
• Drafted and executed validation protocols (IQ, OQ, PQ), including aseptic processing, cleaning, and sterilization validation.
• Conducted supplier audits and managed supplier quality to ensure adherence to regulatory and quality requirements.
• Provided technical expertise in process validation, technology transfer, and manufacturing process improvements.
• Developed and reviewed documentation for regulatory submissions, design controls, and post-market surveillance.
• Led CAPA investigations and remediation activities, ensuring timely closure of deviations and compliance gaps.
• Managed Good Distribution Practice (GDP) compliance, including serialization (UDI, SSCC) and cold chain logistics.
• Designed and delivered training programs on quality systems, regulatory compliance, and validation processes.
• Reviewed and validated laboratory equipment, bioreactors, cleanrooms, HVAC systems, and sterilization techniques.
• Contributed to process improvement initiatives using Lean, Six Sigma, Kaizen, and risk management methodologies.