Siegfried Malta Ltd in Malta is looking to recruit a QA Senior Specialist (Maltese Speaking)
to join their team on a full-time basis. The ideal candidate will be responsible for Investigations & CAPAs, including the overall co-ordination of the respective section.
The chosen candidate will be responsible for:
Education and Experience:
- Managing investigation reports and CAPAs, ensuring accurate, complete, logical, and well-documented investigations whilst verifying that the scope of the investigation and root cause analysis are adequate;
- Coordinating the overall CAPA management by providing guidance to other departments during investigations, working closely with customers, CAPAs implementation and monitoring applications in liaison with QA managers;
- Ensures that state of the art root cause (fishbone, 5 why’s etc.) analyses are performed and that the documentation of these actions are GMP compliant;
- Maintaining CAPA databases such as Excel and eventually Trackwise;
- Gathers and analyses data in support of investigations and trend analysis;
- Approves DR and CAPA on behalf of the QP;
- Participates in customer and Regulatory audits from a CAPA management system standpoint.
- A Bachelor’s degree in Life Science or a related discipline;
- Previous experience in CAPA management within a pharmaceutical industry environment;
- Experience in Root Cause Analysis, investigations, technical/report writing, and extensive knowledge of quality systems.
Siegfried Malta Ltd:
The Siegfried Group is a Swiss-based worldwide life science company which develops and manufactures active pharmaceutical ingredients, intermediates, standard controlled substances, and ready-formulated drugs. Forming part of the Siegfried Group, Siegfried Malta Limited specialises in a high-value and innovative generic portfolio in the solid dosage form range, from bulk to final packaging including capsule filling and high potent FDA approved products.
- Strong communication skills;
- Attention to detail and ability to lead;
- Effective time management and prioritization skills;
- Fluency in written and spoken Maltese and English.