Chief Quality Officer

Our organization is seeking a Quality Assurance Professional to join our team. In this role, you will be responsible for ensuring compliance with regulatory requirements and maintaining high-quality standards throughout our operations.

The successful candidate will possess excellent analytical skills, attention to detail, and strong organizational abilities. They should also have a solid understanding of GMP regulations and industry quality standards.

Responsibilities:

• Contribute to the development, maintenance, and continuous improvement of our Quality Management System
• Draft, revise, and review Quality procedures, SOPs, and other relevant documentation
• Ensure compliance with approved product dossier and regulatory requirements
• Participate in investigations of Out of Specification (OOS) and Out of Trend (OOT) results, deviations, and customer complaints
• Monitor and track CAPA implementation and effectiveness
• Contribute to risk assessments related to nitrosamine impurities, elemental impurities, and other product or process-related risks
• Participate in media fill studies and other validation or qualification activities
• Participate in internal/external audits and support drafting of audit reports
• Collection, compilation, and assessment of statistical quality data and metrics to identify trends and areas for improvement
• Contribute to GMP training programs and maintain accurate training records
• Support the preparation of Annual Product Quality Reviews (APQRs) and other quality reports
• Assist in the preparation and monitoring of Change Control documents
• Issue and review Process Validation Protocols/Reports
• Communicate effectively with internal departments as well as customers

Requirements:

• Bachelor's degree in Pharmacy, Chemistry, Biology, Chemical Engineering, or related field
• Fluency in English both written and oral
• Excellent computer literacy (MS Office)
• Previous professional experience of at least 1-2 years in Quality Assurance or related field in pharmaceutical or biotechnology industry (optional)

Benefits:

• Competitive salary
• Private insurance
• Personal development opportunities

We offer a challenging and dynamic work environment where you can grow professionally and develop new skills. If you are passionate about quality assurance and want to make a difference, apply now