Job Title: Quality Assurance Manager
This position oversees the implementation, maintenance, and continuous improvement of quality management systems (QMS) in a manufacturing facility. The successful candidate will ensure compliance with regulatory requirements and optimize product throughput.
The Quality Assurance Manager will also perform Qualified Person (QP) certification for products released to market, manage site quality operations, and coordinate batch certification activities. They will communicate issues impacting release to management and supply chain stakeholders.
Key responsibilities include reviewing batch documentation related to manufacture and testing, certifying products for release in accordance with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and relevant legislation. Additionally, the Quality Assurance Manager will support investigations into quality non-conformances, complaints, recalls, and batch issues.
Other duties include establishing and monitoring key performance indicators (KPIs) for quality activities, overseeing the site Change Review Board, managing complaints and recalls, ensuring timely completion of audits, and coordinating site training on QMS processes and standard operating procedures (SOPs). The Quality Assurance Manager must maintain accurate records of authorized activities and stay up-to-date on relevant legislation, guidelines, and industry practices.
Requirements:
* Eligibility to be named on a manufacturer's license as a Qualified Person under EU Directive 83/EC
* Minimum of 5 years' quality management experience in the pharmaceutical industry
* Well-organized, effective communication skills at all levels, reliability, IT literacy, and project management ability