QA Manager

Description

Position Summary: We are seeking a quality assurance professional to lead and supervise quality functions, implementing and optimizing the Integrated Management System. Key Highlights: 1. Leadership in deviation investigations and CAPA management. 2. Implementation and optimization of the Integrated Quality Management System. 3. Management of internal and external audits, and oversight of validations. We seek a quality assurance professional with experience to lead and supervise various functions within the area. The role involves conducting investigations into deviations, non-conformities, out-of-specification (OOS) results, and out-of-trend (OOT) results, ensuring rigorous root cause determination. The full CAPA (Corrective and Preventive Actions) lifecycle will be managed—from initiation through to effectiveness verification. The candidate will be responsible for implementing, maintaining, and optimizing the Integrated Quality Management System, ensuring consistent compliance with Good Manufacturing Practices (GMP). This includes drafting, reviewing, and approving Standard Operating Procedures (SOPs) and all relevant technical documentation. Planning and executing internal audits, as well as preparing for and actively participating in regulatory inspections, customer audits, and supplier audits, will be fundamental responsibilities. Additionally, oversight of validation and qualification activities—including processes, analytical methods, cleaning, and computerized systems—will be required. The position also encompasses management of the Change Control system, evaluating the impact of any proposed change on quality and regulatory compliance, as well as supplier evaluation and approval, and management of quality complaints and third-party follow-up. The professional is expected to progressively develop increasing autonomy in technical decision-making and assume comprehensive supervision of the department. Bachelor’s degree in Health Sciences (Pharmacy, Chemistry, Biology, or related fields). Minimum 5 years of experience in quality assurance roles. Intermediate-to-advanced level of English (B2).