Quality Systems Senior Specialist (m/f/o)

Tasks

• Supporting the development, control, and improvement of the company's quality principles in accordance with national and international GMP Guidelines (e.g., cGMP, ICH, 21CFR) and internal quality requirements
• Managing, monitoring, supporting, and executing all tasks related to change controls
• Overseeing and maintaining the company documentation system to ensure effective control of quality documentation such as SOPs, Forms, Site Master File, analytical methods, batch records, etc.
• Administering the company training system, ensuring personnel are fully competent to undertake their respective tasks
• Coordinating and delivering Induction and GMP refresher training to employees
• Participating in and managing the Site Internal Audit Program
• Coordinating Client and Regulatory Audits conducted at the Malta site
• Managing and coordinating the Pest Control Program

Requirements

• A tertiary or post-secondary level of education in life sciences or a related field
• Proven experience working within Pharmaceutical Quality Systems will be considered an asset
• Familiarity with electronic management systems such as Trackwise, Labware, and SAP
• Strong interpersonal and communication skills, both orally and in writing
• Excellent organizational abilities with an eye for detail
• The capability to analyze and troubleshoot problems, identify solutions, and recommend and implement methods, procedures, and/or techniques for resolution

Viviana Costa