Job Description
- Quality Assurance Management: Oversee and support quality assurance activities to ensure compliance with GMP regulations, FDA guidelines, and other relevant standards.
- Documentation: Review and approve quality-related documentation, including batch records, SOPs (Standard Operating Procedures), and deviation reports. Ensure that all documentation is accurate, complete, and compliant with regulatory requirements.
- Audits and Inspections: Conduct internal audits and inspections to assess adherence to quality standards and identify areas for improvement. Prepare for and support external audits and regulatory inspections.
- Deviation Management: Investigate and manage deviations, non-conformances, and CAPAs (Corrective and Preventive Actions). Ensure timely and effective resolution of quality issues.
- Quality Control: Collaborate with quality control teams to monitor and ensure product quality through testing and inspection processes. Review and approve test results and quality control reports.
- Training: Provide training and support to staff on quality assurance processes, GMP practices, and regulatory requirements.
- Continuous Improvement: Participate in continuous improvement initiatives, contributing to the development and implementation of best practices and quality enhancement strategies.
Requirements
- Bachelor’s degree in a relevant field such as Pharmacy, Life Sciences, Chemistry, or a related discipline. Certifications in quality assurance (e.g., ASQ Certified Quality Auditor) are a plus.
- Experience in quality assurance within the pharmaceutical industry, with a solid understanding of GMP regulations and quality systems.
- Strong knowledge of pharmaceutical regulations (FDA, EMA), quality assurance principles, and industry best practices.
- Excellent analytical, organizational, and problem-solving skills. Ability to interpret and apply regulatory requirements effectively. Strong attention to detail and accuracy.
- Effective written and verbal communication skills, with the ability to interact professionally with various stakeholders and present information clearly.
