Senior Quality Assurance Engineer

Job Responsibilities:

• Oversee quality assurance activities throughout the product lifecycle, from development to manufacturing and distribution.
• Develop and maintain quality assurance policies and procedures in line with industry regulations and standards. Prepare and review documentation for regulatory submissions and audits.
• Design and execute validation and verification protocols for manufacturing processes, equipment, and systems. Ensure that validation activities meet regulatory requirements and are documented appropriately.
• Lead and participate in internal and external audits, including FDA and other regulatory agency inspections. Address audit findings and implement corrective and preventive actions (CAPAs) to resolve any issues.
• Identify opportunities for process improvements within the quality assurance framework. Implement best practices to enhance product quality and efficiency while maintaining compliance with regulatory standards.
• Provide leadership and mentorship to junior QA staff, offering guidance on best practices, regulatory compliance, and QA processes. Foster a culture of quality and continuous improvement within the QA team.
• Develop and review standard operating procedures (SOPs), quality manuals, and other documentation related to quality assurance. Prepare and present quality reports to senior management and other stakeholders.
• Collaborate with R&D, manufacturing, and other departments to ensure that quality considerations are integrated into product development and manufacturing processes. Communicate effectively with cross-functional teams to address quality issues and ensure alignment with business objectives.

Qualifications:

• Bachelor’s degree in Chemistry, Biology, or a related field. Advanced degrees or certifications in Quality Assurance, Regulatory Affairs, or Pharmaceutical Sciences are a plus.
• Minimum of 5 years of experience in quality assurance within the pharmaceutical industry.
• In-depth knowledge of FDA, EMA, and other international regulatory requirements related to pharmaceutical manufacturing and quality assurance.
• Proficiency in quality management systems (QMS), validation techniques, and GMP compliance. Experience with electronic lab notebooks (ELNs) and quality management software is a plus.
• Strong analytical and problem-solving skills, with the ability to assess complex quality issues and implement effective solutions.
• Excellent verbal and written communication skills. Ability to clearly articulate technical information to both technical and non-technical stakeholders.
• Exceptional attention to detail and a commitment to maintaining high standards of quality and compliance.
• Proven leadership abilities with experience in mentoring and developing QA teams.